—#208775

Product

Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K962826
Affected lot / code info: DYNJ0281516M , Lot Number 19EBW985 ; DYNJ0281516M , Lot Number 19FBS033 ; DYNJ0281516M , Lot Number 19GBE356 ; DYNJ0281516M , Lot Number 19GBN481 ; DYNJ0281516M , Lot Number 19SBC273 ; DYNJ0281516M , Lot Number 19VBH540 ; DYNJ0281516M , Lot Number 19LBS319 ; DYNJ0281516M , Lot Number 20ABZ597 ; DYNJ0281516M , Lot Number 20DBH983 ; DYNJ0281516M , Lot Number 20FBJ183 ; DYNJ0281516M , Lot Number 20HBK308 ; DYNJ0281516M , Lot Number 20JBZ789 ; DYNJ0281516M , Lot Number 20LBU288 ; DYNJ0281516M , Lot Number 21CBD769 ; DYNJ0281516M , Lot Number 21EMF053 ; DYNJ0281516M , Lot Number 21GMB207 ; DYNJ0281516M , Lot Number 21HMD725 ; DYNJ0281516M , Lot Number 21IMF128 ; DYNJ0281516M , Lot Number 21LMC143 ; DYNJ0281516M , Lot Number 22AMF940 ; DYNJ0281516M , Lot Number 22CMC800 ; DYNJ0281516M , Lot Number 22CMD981 ; DYNJ0281516M , Lot Number 22EMG839 ; DYNJ0281516M , Lot Number 22EMH435 ; DYNJ0281516M , Lot Number 22HMC805 ; DYNJ0281516M , Lot Number 22JMA630 ; DYNJ0281516M , Lot Number 22LMA629 ; DYNJ0281516M , Lot Number 23AMB717 ; DYNJ0281516M , Lot Number 23BMI443 ; DYNJ0281516M , Lot Number 23DMG317 ; DYNJ0281516M , Lot Number 23FMC971 ; DYNJ0281516M , Lot Number 23GMD118 ; DYNJ0281516M , Lot Number 23HMH453 ; DYNJ0281516M , Lot Number 23JMB170 ; DYNJ0281516M , Lot Number 23KME384 ; DYNJ0281516M , Lot Number 19AKA641 ; DYNJ0281516M , Lot Number 19BKD684 ; DYNJ0281516M , Lot Number 19DKC345 ; DYNJ0484979B , Lot Number 18LBO447 ; DYNJ0484979B , Lot Number 19CBU327

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 these 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: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208775. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.