(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel...
FDA Device Recall #Z-1127-2022 — Class II — April 11, 2022
Recall Summary
| Recall Number | Z-1127-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 11, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TELEFLEX MEDICAL INC |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 290,809 eaches |
Product Description
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
Reason for Recall
Reports received of torn corrugated breathing tubes.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.
Lot / Code Information
Batch and UDI numbers: (1) Product 20011: KMH21F0393 (01)04026704388769(17)260528(10)KMH21F0393; KMH21F0394 (01)04026704388769(17)260528(10)KMH21F0394; KMH21F0395 (01)04026704388769(17)260528(10)KMH21F0395; KMH21F0412 (01)04026704388769(17)260528(10)KMH21F0412; KMH21H0094 (01)04026704388769(17)260728(10)KMH21H0094; KMH21H0095 (01)04026704388769(17)260728(10)KMH21H0095; KMH21H0096 (01)04026704388769(17)260728(10)KMH21H0096; KMH21H0110 (01)04026704388769(17)260728(10)KMH21H0110; KMH21H0112 (01)04026704388769(17)260728(10)KMH21H0112; KMH21J0109 (01)04026704388769(17)260828(10)KMH21J0109; KMH21J0110 (01)04026704388769(17)260828(10)KMH21J0110; KMH21J0118 (01)04026704388769(17)260828(10)KMH21J0118; KMH21J0121 (01)04026704388769(17)260828(10)KMH21J0121; KMH21J0124 (01)04026704388769(17)260828(10)KMH21J0124; KMH21K0302 (01)04026704388769(17)260928(10)KMH21K0302; KMH21K0303 (01)04026704388769(17)260928(10)KMH21K0303; KMH21K0306 (01)04026704388769(17)260928(10)KMH21K0306; KMH21K0307 (01)04026704388769(17)260928(10)KMH21K0307; KMH21K0308 (01)04026704388769(17)260928(10)KMH21K0308; KMH21K0320 (01)04026704388769(17)260928(10)KMH21K0320; KMH21K0341 (01)04026704388769(17)260928(10)KMH21K0341; KMH21K0345 (01)04026704388769(17)260928(10)KMH21K0345; KMH21L0156 (01)04026704388769(17)261028(10)KMH21L0156; KMH21B0479 (01)04026704388769(17)260128(10)KMH21B0479; KMH21B0480 (01)04026704388769(17)260128(10)KMH21B0480; KMH21B0482 (01)04026704388769(17)260128(10)KMH21B0482; KMH21B0483 (01)04026704388769(17)260128(10)KMH21B0483; KMH21C0229 (01)04026704388769(17)260228(10)KMH21C0229; KMH21C0230 (01)04026704388769(17)260228(10)KMH21C0230; KMH21C0231 (01)04026704388769(17)260228(10)KMH21C0231; KMH21C0232 (01)04026704388769(17)260228(10)KMH21C0232; KMH21C0241 (01)04026704388769(17)260228(10)KMH21C0241; KMH21C0242 (01)04026704388769(17)260228(10)KMH21C0242; KMH21C0245 (01)04026704388769(17)260228(10)KMH21C0245; KMH21C0246 (01)04026704388769(17)260228(10)KMH21C0246; KMH21C0252 (01)04026704388769(17)260228(10)KMH21C0252; KMH21C0366 (01)04026704388769(17)260228(10)KMH21C0366; KMH21C0367 (01)04026704388769(17)260228(10)KMH21C0367; KMH21C0368 (01)04026704388769(17)260228(10)KMH21C0368; KMH21C0377 (01)04026704388769(17)260228(10)KMH21C0377; KMH21C0378 (01)04026704388769(17)260228(10)KMH21C0378; KMH21D0204 (01)04026704388769(17)260328(10)KMH21D0204; KMH21D0205 (01)04026704388769(17)260328(10)KMH21D0205; KMH21D0206 (01)04026704388769(17)260328(10)KMH21D0206; KMH21E0002 (01)04026704388769(17)260428(10)KMH21E0002; KMH21E0003 (01)04026704388769(17)260428(10)KMH21E0003; KMH21E0004 (01)04026704388769(17)260428(10)KMH21E0004; KMH21F0196 (01)04026704388769(17)260528(10)KMH21F0196; KMH21F0197 (01)04026704388769(17)260528(10)KMH21F0197; KMH21F0198 (01)04026704388769(17)260528(10)KMH21F0198; KMH21F0199 (01)04026704388769(17)260528(10)KMH21F0199; and KMH21F0210 (01)04026704388769(17)260528(10)KMH21F0210. (2) Product 22511 KMH21F0419 (01)04026704388783(17)260528(10)KMH21F0419; KMH21F0433 (01)04026704388783(17)260528(10)KMH21F0433; KMH21G0362 (01)04026704388783(17)260628(10)KMH21G0362; KMH21G0363 (01)04026704388783(17)260628(10)KMH21G0363; KMH21G0439 (01)04026704388783(17)260628(10)KMH21G0439; KMH21H0061 (01)04026704388783(17)260728(10)KMH21H0061; KMH21H0171 (01)04026704388783(17)260728(10)KMH21H0171; KMH21H0199 (01)04026704388783(17)260728(10)KMH21H0199; KMH21H0222 (01)04026704388783(17)260728(10)KMH21H0222; KMH21H0248 (01)04026704388783(17)260728(10)KMH21H0248; KMH21J0209 (01)04026704388783(17)260828(10)KMH21J0209; KMH21J0220 (01)04026704388783(17)260828(10)KMH21J0220; KMH21K0168 (01)04026704388783(17)260928(10)KMH21K0168; KMH21K0376 (01)04026704388783(17)260928(10)KMH21K0376; KMH21K0385 (01)04026704388783(17)260928(10)KMH21K0385; KMH21B0490 (01)04026704388783(17)260128(10)KMH21B0490; KMH21C0159 (01)04026704388783(17)260228(10)KMH21C0159; KMH21C0160 (01)04026704388783(17)260228(10)KMH21C0160; KMH21D0172 (01)04026704388783(17)260328(10)KMH21D0172; KMH21D0316 (01)04026704388783(17)260328(10)KMH21D0316; KMH21D0360 (01)04026704388783(17)260328(10)KMH21D0360; KMH21E0024 (01)04026704388783(17)260428(10)KMH21E0024; KMH21E0223 (01)04026704388783(17)260428(10)KMH21E0223; KMH21F0148 (01)04026704388783(17)260528(10)KMH21F0148; KMH21F0232 (01)04026704388783(17)260528(10)KMH21F0232; and KMH21F0272 (01)04026704388783(17)260528(10)KMH21F0272. (3) Product 22512: KMZ21F0898 (01)04026704388790(17)260528(10)KMZ21F0898; KMZ21G0757 (01)04026704388790(17)260628(10)KMZ21G0757; KMZ21G0865 (01)04026704388790(17)260628(10)KMZ21G0865; KMZ21H0006 (01)04026704388790(17)260728(10)KMZ21H0006; KMZ21H0106 (01)04026704388790(17)260728(10)KMZ21H0106; KMZ21J0245 (01)04026704388790(17)260828(10)KMZ21J0245; KMZ21J0302 (01)04026704388790(17)260828(10)KMZ21J0302; KMZ21J0504 (01)04026704388790(17)260828(10)KMZ21J0504; KMZ21J0505 (01)04026704388790(17)260828(10)KMZ21J0505; KMZ21J0538 (01)04026704388790(17)260828(10)KMZ21J0538; KMZ21L0084 (01)04026704388790(17)261028(10)KMZ21L0084; KMZ21L0407 (01)04026704388790(17)261028(10)KMZ21L0407; KMZ21L0660 (01)04026704388790(17)261028(10)KMZ21L0660; KMZ21C0007 (01)04026704388790(17)260228(10)KMZ21C0007; KMZ21C0166 (01)04026704388790(17)260228(10)KMZ21C0166; KMZ21C0372 (01)04026704388790(17)260228(10)KMZ21C0372; KMZ21C0422 (01)04026704388790(17)260228(10)KMZ21C0422; KMZ21C0722 (01)04026704388790(17)260228(10)KMZ21C0722; KMZ21C0744 (01)04026704388790(17)260228(10)KMZ21C0744; KMZ21C0924 (01)04026704388790(17)260228(10)KMZ21C0924; KMZ21C1306 (01)04026704388790(17)260228(10)KMZ21C1306; KMZ21D0858 (01)04026704388790(17)260328(10)KMZ21D0858; KMZ21D0926 (01)04026704388790(17)260328(10)KMZ21D0926; KMZ21D1057 (01)04026704388790(17)260328(10)KMZ21D1057; KMZ21D1116 (01)04026704388790(17)260328(10)KMZ21D1116; KMZ21E0135 (01)04026704388790(17)260428(10)KMZ21E0135; KMZ21E0203 (01)04026704388790(17)260428(10)KMZ21E0203; KMZ21E0360 (01)04026704388790(17)260428(10)KMZ21E0360; KMZ21F0387 (01)04026704388790(17)260528(10)KMZ21F0387; KMZ21F0554 (01)04026704388790(17)260528(10)KMZ21F0554; KMZ21F0595 (01)04026704388790(17)260528(10)KMZ21F0595; and KMZ21F0702 (01)04026704388790(17)260528(10)KMZ21F0702. (4) Product 22552 KMZ21G0680 (01)04026704388851(17)260628(10)KMZ21G0680; KMZ21G0689 (01)04026704388851(17)260628(10)KMZ21G0689; KMZ21G0711 (01)04026704388851(17)260628(10)KMZ21G0711; KMZ21G0801 (01)04026704388851(17)260628(10)KMZ21G0801; KMZ21H0181 (01)04026704388851(17)260728(10)KMZ21H0181; KMZ21H0182 (01)04026704388851(17)260728(10)KMZ21H0182; KMZ21J0246 (01)04026704388851(17)260828(10)KMZ21J0246; KMZ21J0401 (01)04026704388851(17)260828(10)KMZ21J0401; KMZ21J0584 (01)04026704388851(17)260828(10)KMZ21J0584; KMZ21K0364 (01)04026704388851(17)260928(10)KMZ21K0364; KMZ21K0365 (01)04026704388851(17)260928(10)KMZ21K0365; KMZ21K0608 (01)04026704388851(17)260928(10)KMZ21K0608; KMZ21B1212 (01)04026704388851(17)260128(10)KMZ21B1212; KMZ21B1213 (01)04026704388851(17)260128(10)KMZ21B1213; KMZ21B1241 (01)04026704388851(17)260128(10)KMZ21B1241; KMZ21C0130 (01)04026704388851(17)260228(10)KMZ21C0130; KMZ21C1266 (01)04026704388851(17)260228(10)KMZ21C1266; KMZ21D0957 (01)04026704388851(17)260328(10)KMZ21D0957; KMZ21F0181 (01)04026704388851(17)260528(10)KMZ21F0181; KMZ21F0182 (01)04026704388851(17)260528(10)KMZ21F0182; and KMZ21F0518 (01)04026704388851(17)260528(10)KMZ21F0518.
Other Recalls from TELEFLEX MEDICAL INC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1126-2022 | Class II | (1) Gibeck Humid-Vent 2S Flex DC, Product #1773... | Apr 11, 2022 |
| Z-0628-2022 | Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0625-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0623-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0629-2022 | Class I | Arrow-Trerotola PTD Set (Percutaneous Thromboly... | Jan 11, 2022 |
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.