—#208068

Product

Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 6) PRE POST DIALYSIS, Pack Number DYNDC3274; 7) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A

FDA product code: OGR — Ear, Nose, And Throat Surgical Tray
Device class: Class 1
Medical specialty: Ear, Nose, Throat
Affected lot / code info: DYNDA1466A, Lot Number 2022040190; SUT20455, Lot Number 2022040190; CHT560, Lot Number 2021092290; MNS4815, Lot Number 2022040190; MNS3560, Lot Number 2021021790; MNS3560, Lot Number 2021092290; MNS3560, Lot Number 2021092890; MNS3560, Lot Number 2022040190; MNS3560, Lot Number 2022071490; MNS3560, Lot Number 2023121290; DYNDC3274, Lot Number 2023121290; DYNDC2859A, Lot Number 2021092290

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

Timeline

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

Source: openFDA Device Recall endpoint. Recall record ID #208068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.