Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7020; 6) CIRCUMCISION TRAY, Pack Name DYNDA2271; 7) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Name CIT6920; 8) NURSERY CIRCUMCISION TRAY, Pack Name CIT4845; 9) PUNCH BIOPSY KIT, Pack Name MNS8245; 10) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Name DYNDA2496
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-2775-2024
- 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 distribution.
Lot / Code Info
MNS12670A, Lot Number 2022011090; MNS12670A, Lot Number 2022070690; MNS12670A, Lot Number 2023022190; MNS12670A, Lot Number 2023101890; MNS12670A, Lot Number 2024021590; DYNDH1512A, Lot Number 2022121990; DYNDH1512A, Lot Number 2023101890; CIT6720, Lot Number 2021061490; CIT6715, Lot Number 2022100490; CIT7020, Lot Number 2023010690; DYNDA2271, Lot Number 2023022190; CIT6715, Lot Number 2023082290; CIT7020, Lot Number 2023101890; CIT6715, Lot Number 2023102090; CIT6715, Lot Number 2023120590; CIT6920, Lot Number 2021082390; CIT4845, Lot Number 2021122150; CIT4845, Lot Number 2022052450; MNS8245, Lot Number 2023082490; DYNDA2496, Lot Number 2023012790
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.