Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 6) VANTEX 7FR 3L 16CM CVC BUNDLE US, Pack Number ECVC8050
This recall is currently active, issued August 28, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- April 8, 2024
- Posted
- August 28, 2024
- Recall Number
- Z-2773-2024
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution
worldwide
Lot / Code Info
SPEC4380, Lot Number 2023092590; CIT6325, Lot Number 2023082990; CIT6785A, Lot Number 2022120190; CIT6785A, Lot Number 2023021790; CIT6785A, Lot Number 2023041290; CIT6785A, Lot Number 2023092590; PT215, Lot Number 2023082990; MNS9580, Lot Number 2023082990; ECVC8050, Lot Number 2023082990
Root Cause
Under Investigation by firm
Action Taken
Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request that the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.