—#208175

Product

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 product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: DYNDH1446A, Lot Number 2020102990; MNS11965A, Lot Number 2021061190; MNS11965A, Lot Number 2021072690; MNS11965A, Lot Number 2021083090; MNS11965A, Lot Number 2022041390; MNS11965A, Lot Number 2022091490; MNS11965A, Lot Number 2023041090; MNS12670A, Lot Number 2023060290; DYNDH1512, Lot Number 2021100490; CIT7095, Lot Number 2021061190; CIT6535, Lot Number 2024031880; CIT7020, Lot Number 2021120990; CIT6720, Lot Number 2022032290; CIT6715, Lot Number 2022062290; CIT7210, Lot Number 2022071990; CIT7020, Lot Number 2022091490; CIT7210, Lot Number 2022120590; CIT6715, Lot Number 2023012490; CIT7020, Lot Number 2023030290; CIT7210, Lot Number 2023030990; CIT7210, Lot Number 2023060290; CIT6925, Lot Number 2021081190; CIT6925, Lot Number 2021090290; CIT6925, Lot Number 2022070590; UVT1030, Lot Number 2021072190; UVT1030, Lot Number 2022032290; CIT6780, Lot Number 2021081650; CIT6780, Lot Number 2023092290; CIT6920, Lot Number 2024020290; CIT4845, Lot Number 2023042090; CIT4845, Lot Number 2023070390; CIT4845, Lot Number 2023081090; MNS8245, Lot Number 2022111890; MNS12465, Lot Number 2022072290; MNS12465, Lot Number 2022111890; MNS12465, Lot Number 2023042890; MNS12465, Lot Number 2023102390; MNS12465, Lot Number 2024022190; MNS12465, Lot Number 2024030790; MNS12465, Lot Number 2022022880; DYNDA2496, Lot Number 2023102590

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-04-08
Posted by FDA: 2024-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.