Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIA...
FDA Device Recall #Z-2200-2023 — Class II — May 18, 2023
Recall Summary
| Recall Number | Z-2200-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 18, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 70648 units |
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI KIT , Model Number BSIPIV1010; e) ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011; f) PICC INSERTION TRAY , Model Number CVI3805; g) PEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B; h) CENTRAL LINE INSERTION TRAY , Model Number DT19810; i) NEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A; j) USG PIV KIT , Model Number DYNDV2536; k) ULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547; l) USG PIV KIT , Model Number DYNDV2567; m) POLY MIDLINE KIT 4F SL , Model Number DYNJ68937A; n) PICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB; o) PICC KIT 5F DL PL MB , Model Number DYNJ70152MB; p) MIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB; q) MIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB; r) ULTRASOUND GUIDED PIV KIT , Model Number IVS3420B; s) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C; t) FLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770; u) ULTRASOUND GUIDED PIV KIT , Model Number IVS3900A; v) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A; w) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B; x) ULTRASOUND GUIDED PIV KIT , Model Number IVS4005; y) MIDLINE KIT 4F SL MB , Model Number MID0001; z) MIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003; aa) MIDLINE BUNDLE 4FR SL , Model Number MID0005; bb) MIDLINE KIT 4F SL PL MB , Model Number PICC0009A; cc) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010; dd) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011; ee) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012; ff) PICC BUNDLE 5FR DL , Model Number PICC0013; gg) VANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A; hh) VANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Lot / Code Information
All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892; b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864; c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939; d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526; e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310; f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088; g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421; h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659; i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983; j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679; k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249; l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458; m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542; n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805; o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823; p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412; q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429; r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060; s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957; t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233; u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777; v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667; w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338; x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145; y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628; z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337; aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184; bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238; cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115; dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845; ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494; ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811; gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555; hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562
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| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
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.