—#208179

Product

Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT6720; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 9) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920

FDA product code: OHG — Circumcision Tray
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: DYNDH1512A, Lot Number 2023030190; CIT6535, Lot Number 2023090580; CIT7095, Lot Number 2020121190; CIT7095, Lot Number 2022031590; CIT6860A, Lot Number 2021111580; CIT6860A, Lot Number 2022010480; CIT6860A, Lot Number 2022041880; CIT6860A, Lot Number 2022053080; CIT6860A, Lot Number 2022062080; CIT6860A, Lot Number 2022121280; CIT6860A, Lot Number 2023032080; CIT6860A, Lot Number 2023062680; CIT6860A, Lot Number 2023071780; CIT6860A, Lot Number 2023090580; CIT6860A, Lot Number 2023091180; CIT6860A, Lot Number 2023111380; CIT6860A, Lot Number 2024020580; DYNDA2271, Lot Number 2021072890; CIT6720, Lot Number 2021080390; DYNDA2271, Lot Number 2021083190; DYNDA2271, Lot Number 2021100790; DYNDA2271, Lot Number 2022010390; CIT6720, Lot Number 2021121590; DYNDA2271, Lot Number 2022042590; CIT7020, Lot Number 2022061390; CIT6720, Lot Number 2022072790; CIT6720, Lot Number 2022091690; CIT7020, Lot Number 2022110990; CIT6720, Lot Number 2022110990; CIT6720, Lot Number 2023063090; DYNDA2271, Lot Number 2023063090; CIT7020, Lot Number 2023080890; DYNDA2271, Lot Number 2023112990; CIT7020, Lot Number 2024020890; DYNDA2271, Lot Number 2024030690; CIT6780, Lot Number 2021110350; CIT6780, Lot Number 2022070750; CIT6780, Lot Number 2022072150; CIT6780, Lot Number 2023030190; CIT6780, Lot Number 2024022890; CIT6920, Lot Number 2022042590

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 #208179. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.