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Open, Classified

Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Number CIT6535; 6) CIRCUMCISION KIT, Pack Number CIT7095; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) CIRCUMCISION TRAY, Pack Number CIT6720; 9) CIRCUMCISION TRAY, Pack Number CIT6715; 10) CIRCUMCISION TRAY, Pack Number CIT7210; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) DISPOSABLE NICU UMBILICAL INSERTION TRAY, Pack Number UVT1030; 13) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 14) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 15) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 16) PUNCH BIOPSY KIT, Pack Number MNS8245; 17) RETINAL INJECTION KIT, Pack Number MNS12465; 18) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496

FDA Recall Z-2776-2024 · Posted 2024-08-28

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeLRP
Date Initiated2024-04-08

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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