—#208144

Product

Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512

FDA product code: PXP — Breast Biopsy / Localization Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: CIT6715, Lot Number 2023071390; CIT6920, Lot Number 2021071290; CIT7095, Lot Number 2021071290; CIT7095, Lot Number 2022110390; MNS12465, Lot Number 2023081590; DYNDH1512, Lot Number 2021070790; DYNDH1512, Lot Number 2021080290; DYNDH1512, Lot Number 2022011990; DYNDH1512A, Lot Number 2022110390; DYNDH1512A, Lot Number 2023052290; DYNDH1512A, Lot Number 2023071390; DYNDH1512A, Lot Number 2024022690

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 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

Timeline

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

Source: openFDA Device Recall endpoint. Recall record ID #208144. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.