Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only...
FDA Device Recall #Z-0075-2023 — Class I — August 29, 2022
Recall Summary
| Recall Number | Z-0075-2023 |
| Classification | Class I — Serious risk |
| Date Initiated | August 29, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TELEFLEX LLC |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 355 units |
Product Description
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
Reason for Recall
Incidents of device splitting or detaching during use
Distribution Pattern
US nationwide distribution
Lot / Code Information
a) 19261T, UDI: (01)04026704400492(17)250528(10)20FT51, (01)04026704400492(17)251028(10)KMH20L0409, (01)04026704400492(17)251228(10)KMH21A0086, (01)04026704400492(17)251228(10)KMH21A0190, (01)04026704400492(17)260128(10)KMH21B0163, (01)04026704400492(17)260128(10)KMH21B0343, (01)04026704400492(17)260128(10)KMH21B0355, (01)04026704400492(17)260228(10)KMH21C0177, (01)04026704400492(17)260228(10)KMH21C0387, (01)04026704400492(17)260528(10)KMH21F0156, (01)04026704400492(17)260528(10)KMH21F0337, (01)04026704400492(17)260628(10)KMH21G0426, (01)04026704400492(17)260828(10)KMH21J0020, (01)04026704400492(17)260828(10)KMH21J0245, (01)04026704400492(17)260928(10)KMH21K0142, (01)04026704400492(17)261128(10)KMH21M0182, (01)04026704400492(17)270128(10)KMH22B0151, (01)04026704400492(17)270128(10)KMH22B0248; b) 19262T, UDI: (01)04026704400508(17)250528(10)202025, (01)04026704400508(17)250528(10)202026, (01)04026704400508(17)250628(10)202030, (01)04026704400508(17)250828(10)KMZ20J0163, (01)04026704400508(17)250828(10)KMZ20J0171, (01)04026704400508(17)250828(10)KMZ20J0582, (01)04026704400508(17)250828(10)KMZ20J0586, (01)04026704400508(17)250828(10)KMZ20J0587, (01)04026704400508(17)250928(10)KMZ20K0681, (01)04026704400508(17)251028(10)KMZ20L0968, (01)04026704400508(17)251028(10)KMZ20L0977, (01)04026704400508(17)251028(10)KMZ20L1275, (01)04026704400508(17)251128(10)KMZ20M0544, (01)04026704400508(17)251128(10)KMZ20M0661, (01)04026704400508(17)251228(10)KMZ21A0175, (01)04026704400508(17)251228(10)KMZ21A0186, (01)04026704400508(17)251228(10)KMZ21A0187, (01)04026704400508(17)251228(10)KMZ21A0208, (01)04026704400508(17)260128(10)KMZ21B0483, (01)04026704400508(17)260128(10)KMZ21B0485, (01)04026704400508(17)260128(10)KMZ21B0495, (01)04026704400508(17)260128(10)KMZ21B0811, (01)04026704400508(17)260128(10)KMZ21B0918, (01)04026704400508(17)260128(10)KMZ21B1172, (01)04026704400508(17)260228(10)KMZ21C0884, (01)04026704400508(17)260228(10)KMZ21C0910, (01)04026704400508(17)260228(10)KMZ21C0929, (01)04026704400508(17)260228(10)KMZ21C0931, (01)04026704400508(17)260328(10)KMZ21D0419, (01)04026704400508(17)260528(10)KMZ21F0223, (01)04026704400508(17)260528(10)KMZ21F0260, (01)04026704400508(17)260528(10)KMZ21F0528, (01)04026704400508(17)260628(10)KMZ21G0728, (01)04026704400508(17)260628(10)KMZ21G0735, (01)04026704400508(17)260628(10)KMZ21G0739, (01)04026704400508(17)260728(10)KMZ21H0055, (01)04026704400508(17)260828(10)KMZ21J0006, (01)04026704400508(17)260828(10)KMZ21J0007, (01)04026704400508(17)260828(10)KMZ21J0008, (01)04026704400508(17)260928(10)KMZ21K0510, (01)04026704400508(17)260928(10)KMZ21K0524, (01)04026704400508(17)260928(10)KMZ21K0539, (01)04026704400508(17)260928(10)KMZ21K0572, (01)04026704400508(17)260928(10)KMZ21K0578, (01)04026704400508(17)260928(10)KMZ21K0592, (01)04026704400508(17)260928(10)KMZ21K0952, (01)04026704400508(17)261028(10)KMZ21L0218, (01)04026704400508(17)261128(10)KMZ21M0674, (01)04026704400508(17)270128(10)KMZ22B0125, (01)04026704400508(17)270128(10)KMZ22B0345, (01)04026704400508(17)270128(10)KMZ22B0809, (01)04026704400508(17)270128(10)KMZ22B0828, (01)04026704400508(17)270128(10)KMZ22B0838, (01)04026704400508(17)270128(10)KMZ22B0869, (01)04026704400508(17)270228(10)KMZ22C0659; c) 19272T, UDI: (01)04026704400515(17)250528(10)202025, (01)04026704400515(17)250528(10)202026, (01)04026704400515(17)250628(10)202027, (01)04026704400515(17)250628(10)202028, (01)04026704400515(17)250628(10)202029, (01)04026704400515(17)250628(10)202030, (01)04026704400515(17)250628(10)202031, (01)04026704400515(17)250628(10)KMZ20G0005, (01)04026704400515(17)250628(10)KMZ20G0026, (01)04026704400515(17)250628(10)KMZ20G0105, (01)04026704400515(17)250628(10)KMZ20G0112, (01)04026704400515(17)250728(10)KMZ20H0081, (01)04026704400515(17)250728(10)KMZ20H0096, (01)04026704400515(17)250728(10)KMZ20H0158, (01)04026704400515(17)250728(10)KMZ20H0379, (01)04026704400515(17)250728(10)KMZ20H0530, (01)04026704400515(17)250728(10)KMZ20H0540, (01)04026704400515(17)250728(10)KMZ20H0564, (01)04026704400515(17)250728(10)KMZ20H0812, (01)04026704400515(17)250728(10)KMZ20H0841, (01)04026704400515(17)250728(10)KMZ20H1021, (01)04026704400515(17)250728(10)KMZ20H1024, (01)04026704400515(17)250728(10)KMZ20H1031, (01)04026704400515(17)250828(10)KMZ20J0092, (01)04026704400515(17)250828(10)KMZ20J0102, (01)04026704400515(17)250828(10)KMZ20J0227, (01)04026704400515(17)250828(10)KMZ20J0441, (01)04026704400515(17)250828(10)KMZ20J0535, (01)04026704400515(17)250828(10)KMZ20J0551, (01)04026704400515(17)250828(10)KMZ20J0566, (01)04026704400515(17)250828(10)KMZ20J0640, (01)04026704400515(17)250828(10)KMZ20J0654, (01)04026704400515(17)250828(10)KMZ20J0663, (01)04026704400515(17)250828(10)KMZ20J0893, (01)04026704400515(17)250828(10)KMZ20J0958, (01)04026704400515(17)250928(10)KMZ20K0034, (01)04026704400515(17)250928(10)KMZ20K0196, (01)04026704400515(17)250928(10)KMZ20K0236, (01)04026704400515(17)250928(10)KMZ20K0430, (01)04026704400515(17)250928(10)KMZ20K0659, (01)04026704400515(17)250928(10)KMZ20K0662, (01)04026704400515(17)250928(10)KMZ20K0838, (01)04026704400515(17)250928(10)KMZ20K0946, (01)04026704400515(17)250928(10)KMZ20K1260, (01)04026704400515(17)250928(10)KMZ20K1289, (01)04026704400515(17)250928(10)KMZ20K1294, (01)04026704400515(17)250928(10)KMZ20K1310, (01)04026704400515(17)250928(10)KMZ20K1339, (01)04026704400515(17)250928(10)KMZ20K1340, (01)04026704400515(17)251028(10)KMZ20L0003, (01)04026704400515(17)251028(10)KMZ20L0030, (01)04026704400515(17)251028(10)KMZ20L0031, (01)04026704400515(17)251028(10)KMZ20L0117, (01)04026704400515(17)251028(10)KMZ20L0214, (01)04026704400515(17)251028(10)KMZ20L0351, (01)04026704400515(17)251028(10)KMZ20L0359, (01)04026704400515(17)251028(10)KMZ20L0499, (01)04026704400515(17)251028(10)KMZ20L0537, (01)04026704400515(17)251028(10)KMZ20L0706, (01)04026704400515(17)251028(10)KMZ20L0724, (01)04026704400515(17)251028(10)KMZ20L0885, (01)04026704400515(17)251028(10)KMZ20L0886, (01)04026704400515(17)251028(10)KMZ20L0933, (01)04026704400515(17)251028(10)KMZ20L0945, (01)04026704400515(17)251028(10)KMZ20L1056, (01)04026704400515(17)251028(10)KMZ20L1091, (01)04026704400515(17)251028(10)KMZ20L1103, (01)04026704400515(17)251028(10)KMZ20L1104, (01)04026704400515(17)251128(10)KMZ20M0387, (01)04026704400515(17)251128(10)KMZ20M0777, (01)04026704400515(17)251128(10)KMZ20M0778, (01)04026704400515(17)251128(10)KMZ20M0787, (01)04026704400515(17)251128(10)KMZ20M0822, (01)04026704400515(17)251128(10)KMZ20M0842, (01)04026704400515(17)251128(10)KMZ20M0938, (01)04026704400515(17)251128(10)KMZ20M0967, (01)04026704400515(17)251128(10)KMZ20M0990, (01)04026704400515(17)251128(10)KMZ20M1249, (01)04026704400515(17)251128(10)KMZ20M1250, (01)04026704400515(17)251128(10)KMZ20M1257, (01)04026704400515(17)251128(10)KMZ20M1267, (01)04026704400515(17)251228(10)KMZ21A0012, (01)04026704400515(17)251228(10)KMZ21A0024, (01)04026704400515(17)251228(10)KMZ21A0117, (01)04026704400515(17)251228(10)KMZ21A0126, (01)04026704400515(17)251228(10)KMZ21A0155, (01)04026704400515(17)251228(10)KMZ21A0162, (01)04026704400515(17)251228(10)KMZ21A0164, (01)04026704400515(17)251228(10)KMZ21A0203, (01)04026704400515(17)251228(10)KMZ21A0218, (01)04026704400515(17)251228(10)KMZ21A0226, (01)04026704400515(17)251228(10)KMZ21A0368, (01)04026704400515(17)251228(10)KMZ21A0618, (01)04026704400515(17)251228(10)KMZ21A0635, (01)04026704400515(17)251228(10)KMZ21A0693, (01)04026704400515(17)251228(10)KMZ21A0706, (01)04026704400515(17)251228(10)KMZ21A0714, (01)04026704400515(17)251228(10)KMZ21A0725, (01)04026704400515(17)251228(10)KMZ21A0734, (01)04026704400515(17)251228(10)KMZ21A0950, (01)04026704400515(17)260128(10)KMZ21B0101, (01)04026704400515(17)260128(10)KMZ21B0163, (01)04026704400515(17)260128(10)KMZ21B0181, (01)04026704400515(17)260128(10)KMZ21B0183, (01)04026704400515(17)260128(10)KMZ21B0185, (01)04026704400515(17)260128(10)KMZ21B0189, (01)04026704400515(17)260128(10)KMZ21B0227, (01)04026704400515(17)260128(10)KMZ21B0234, (01)04026704400515(17)260128(10)KMZ21B0305, (01)04026704400515(17)260128(10)KMZ21B0320, (01)04026704400515(17)260128(10)KMZ21B0417, (01)04026704400515(17)260128(10)KMZ21B0421, (01)04026704400515(17)260128(10)KMZ21B0435, (01)04026704400515(17)260128(10)KMZ21B0465, (01)04026704400515(17)260128(10)KMZ21B0471, (01)04026704400515(17)260128(10)KMZ21B0479, (01)04026704400515(17)260128(10)KMZ21B0533, (01)04026704400515(17)260128(10)KMZ21B0689, (01)04026704400515(17)260128(10)KMZ21B1171, (01)04026704400515(17)260228(10)KMZ21C0270, (01)04026704400515(17)260228(10)KMZ21C0388, (01)04026704400515(17)260228(10)KMZ21C0398, (01)04026704400515(17)260228(10)KMZ21C0883, (01)04026704400515(17)260228(10)KMZ21C1159, (01)04026704400515(17)260228(10)KMZ21C1160, (01)04026704400515(17)260228(10)KMZ21C1358, (01)04026704400515(17)260328(10)KMZ21D0420, (01)04026704400515(17)260528(10)KMZ21F0227, (01)04026704400515(17)260528(10)KMZ21F0265, (01)04026704400515(17)260528(10)KMZ21F0296, (01)04026704400515(17)260528(10)KMZ21F0335, (01)04026704400515(17)260528(10)KMZ21F0375, (01)04026704400515(17)260528(10)KMZ21F0430, (01)04026704400515(17)260528(10)KMZ21F0467, (01)04026704400515(17)260528(10)KMZ21F0468, (01)04026704400515(17)260528(10)KMZ21F0478, (01)04026704400515(17)260528(10)KMZ21F0501, (01)04026704400515(17)260528(10)KMZ21F0517, (01)04026704400515(17)260528(10)KMZ21F0534, (01)04026704400515(17)260528(10)KMZ21F0550, (01)04026704400515(17)260528(10)KMZ21F0551, (01)04026704400515(17)260528(10)KMZ21F0552, (01)04026704400515(17)260528(10)KMZ21F0557, (01)04026704400515(17)260528(10)KMZ21F0567, (01)04026704400515(17)260528(10)KMZ21F0568, (01)04026704400515(17)260528(10)KMZ21F0588, (01)04026704400515(17)260528(10)KMZ21F0594, (01)04026704400515(17)260528(10)KMZ21F0742, (01)04026704400515(17)260528(10)KMZ21F0777, (01)04026704400515(17)260628(10)KMZ21G0399, (01)04026704400515(17)260628(10)KMZ21G0403, (01)04026704400515(17)260628(10)KMZ21G0404, (01)04026704400515(17)260628(10)KMZ21G0751, (01)04026704400515(17)260628(10)KMZ21G0765, (01)04026704400515(17)260628(10)KMZ21G0770, (01)04026704400515(17)260628(10)KMZ21G0778, (01)04026704400515(17)260628(10)KMZ21G0786, (01)04026704400515(17)260628(10)KMZ21G0800, (01)04026704400515(17)260628(10)KMZ21G0806, (01)04026704400515(17)260628(10)KMZ21G0838, (01)04026704400515(17)260628(10)KMZ21G0911, (01)04026704400515(17)260628(10)KMZ21G0912, (01)04026704400515(17)260628(10)KMZ21G0917, (01)04026704400515(17)260628(10)KMZ21G0954, (01)04026704400515(17)260628(10)KMZ21G0955, (01)04026704400515(17)260628(10)KMZ21G0956, (01)04026704400515(17)260628(10)KMZ21G0964, (01)04026704400515(17)260628(10)KMZ21G0971, (01)04026704400515(17)260628(10)KMZ21G0982, (01)04026704400515(17)260628(10)KMZ21G0986, (01)04026704400515(17)260628(10)KMZ21G0992, (01)04026704400515(17)260628(10)KMZ21G0993, (01)04026704400515(17)260628(10)KMZ21G0995, (01)04026704400515(17)260628(10)KMZ21G1001, (01)04026704400515(17)260628(10)KMZ21G1008, (01)04026704400515(17)260628(10)KMZ21G1017, (01)04026704400515(17)260628(10)KMZ21G1037, (01)04026704400515(17)260628(10)KMZ21G1038, (01)04026704400515(17)260728(10)KMZ21H0115, (01)04026704400515(17)260728(10)KMZ21H0257, (01)04026704400515(17)260728(10)KMZ21H0299, (01)04026704400515(17)260728(10)KMZ21H0405, (01)04026704400515(17)260728(10)KMZ21H0429, (01)04026704400515(17)260728(10)KMZ21H0431, (01)04026704400515(17)260728(10)KMZ21H0433, (01)04026704400515(17)260728(10)KMZ21H0435, (01)04026704400515(17)260728(10)KMZ21H0504, (01)04026704400515(17)260728(10)KMZ21H0508, (01)04026704400515(17)260728(10)KMZ21H0526, (01)04026704400515(17)260728(10)KMZ21H0560, (01)04026704400515(17)260728(10)KMZ21H0561, (01)04026704400515(17)260828(10)KMZ21J0050, (01)04026704400515(17)260828(10)KMZ21J0077, (01)04026704400515(17)260828(10)KMZ21J0088, (01)04026704400515(17)260828(10)KMZ21J0089, (01)04026704400515(17)260828(10)KMZ21J0446, (01)04026704400515(17)260828(10)KMZ21J0447, (01)04026704400515(17)260828(10)KMZ21J0448, (01)04026704400515(17)260828(10)KMZ21J0484, (01)04026704400515(17)260828(10)KMZ21J0485, (01)04026704400515(17)260828(10)KMZ21J0534, (01)04026704400515(17)260828(10)KMZ21J0546, (01)04026704400515(17)260828(10)KMZ21J0554, (01)04026704400515(17)260828(10)KMZ21J0555, (01)04026704400515(17)260828(10)KMZ21J0570, (01)04026704400515(17)260828(10)KMZ21J0571, (01)04026704400515(17)260828(10)KMZ21J0579, (01)04026704400515(17)260828(10)KMZ21J0580, (01)04026704400515(17)260928(10)KMZ21K0045, (01)04026704400515(17)260928(10)KMZ21K0114, (01)04026704400515(17)260928(10)KMZ21K0163, (01)04026704400515(17)260928(10)KMZ21K0164, (01)04026704400515(17)260928(10)KMZ21K0266, (01)04026704400515(17)260928(10)KMZ21K0274, (01)04026704400515(17)260928(10)KMZ21K0295, (01)04026704400515(17)260928(10)KMZ21K0299, (01)04026704400515(17)260928(10)KMZ21K0308, (01)04026704400515(17)260928(10)KMZ21K0314, (01)04026704400515(17)260928(10)KMZ21K0318, (01)04026704400515(17)260928(10)KMZ21K0323, (01)04026704400515(17)260928(10)KMZ21K0452, (01)04026704400515(17)260928(10)KMZ21K0453, (01)04026704400515(17)260928(10)KMZ21K0509, (01)04026704400515(17)260928(10)KMZ21K0926, (01)04026704400515(17)260928(10)KMZ21K0953, (01)04026704400515(17)260928(10)KMZ21K0954, (01)04026704400515(17)261028(10)KMZ21L0047, (01)04026704400515(17)261028(10)KMZ21L0070, (01)04026704400515(17)261028(10)KMZ21L0074, (01)04026704400515(17)261028(10)KMZ21L0077, (01)04026704400515(17)261028(10)KMZ21L0079, (01)04026704400515(17)261028(10)KMZ21L0219, (01)04026704400515(17)261028(10)KMZ21L0220, (01)04026704400515(17)261028(10)KMZ21L0238, (01)04026704400515(17)261028(10)KMZ21L0239, (01)04026704400515(17)261028(10)KMZ21L0244, (01)04026704400515(17)261028(10)KMZ21L0295, (01)04026704400515(17)261028(10)KMZ21L0296, (01)04026704400515(17)261028(10)KMZ21L0307, (01)04026704400515(17)261028(10)KMZ21L0308, (01)04026704400515(17)261028(10)KMZ21L0316, (01)04026704400515(17)261028(10)KMZ21L0333, (01)04026704400515(17)261028(10)KMZ21L0334, (01)04026704400515(17)261028(10)KMZ21L0337, (01)04026704400515(17)261028(10)KMZ21L0344, (01)04026704400515(17)261028(10)KMZ21L0367, (01)04026704400515(17)261028(10)KMZ21L0368, (01)04026704400515(17)261028(10)KMZ21L0382, (01)04026704400515(17)261028(10)KMZ21L0389, (01)04026704400515(17)261028(10)KMZ21L0541, (01)04026704400515(17)261028(10)KMZ21L0798, (01)04026704400515(17)261028(10)KMZ21L0878, (01)04026704400515(17)261028(10)KMZ21L0880, (01)04026704400515(17)261028(10)KMZ21L0901, (01)04026704400515(17)261028(10)KMZ21L0924, (01)04026704400515(17)261128(10)KMZ21M0050, (01)04026704400515(17)261128(10)KMZ21M0690, (01)04026704400515(17)261128(10)KMZ21M0692, (01)04026704400515(17)261128(10)KMZ21M0719, (01)04026704400515(17)261128(10)KMZ21M0756, (01)04026704400515(17)261128(10)KMZ21M0781, (01)04026704400515(17)261128(10)KMZ21M0786, (01)04026704400515(17)261128(10)KMZ21M0790, (01)04026704400515(17)261128(10)KMZ21M0805, (01)04026704400515(17)261228(10)KMZ22A0635, (01)04026704400515(17)261228(10)KMZ22A0636, (01)04026704400515(17)261228(10)KMZ22A0650, (01)04026704400515(17)261228(10)KMZ22A0871, (01)04026704400515(17)270128(10)KMZ22B0130, (01)04026704400515(17)270128(10)KMZ22B0131, (01)04026704400515(17)270128(10)KMZ22B0192, (01)04026704400515(17)270128(10)KMZ22B0509, (01)04026704400515(17)270128(10)KMZ22B0524, (01)04026704400515(17)270128(10)KMZ22B0525, (01)04026704400515(17)270128(10)KMZ22B0556, (01)04026704400515(17)270128(10)KMZ22B0557, (01)04026704400515(17)270128(10)KMZ22B0784, (01)04026704400515(17)270128(10)KMZ22B0785, (01)04026704400515(17)270228(10)KMZ22C0395, (01)04026704400515(17)270228(10)KMZ22C0620, (01)04026704400515(17)270228(10)KMZ22C0802, (01)04026704400515(17)270228(10)KMZ22C0803.
Other Recalls from TELEFLEX LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1834-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet S... | May 25, 2023 |
| Z-1875-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain - M... | May 25, 2023 |
| Z-1937-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain - M... | May 25, 2023 |
| Z-1889-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye, High V... | May 25, 2023 |
| Z-1905-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet... | May 25, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.