Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3015-2024
• Recall Event ID: 94583
• Product Classification: Tray, surgical, instrument - Product Code FSM
• Product: Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Number DYNJ66416; 6) DRAINAGE TRAY , Pack Number DYNJ68767; 7) INCISION AND DRAINAGE TRAY, Pack Number P737057
• Code Information: 146255, Lot Number 23KBP730; 146255, Lot Number 23JBV770; 146255, Lot Number 23BBJ516; 146255, Lot Number 23ABS205; 146255, Lot Number 22LBQ260; 146255, Lot Number 22LBF150; CVI5080, Lot Number 24ABR654 ; CVI5080, Lot Number 24ABS414 ; DYNDA1063, Lot Number 21JBR507 ; DYNJ44599I , Lot Number 21FBO112 ; DYNJ44599I , Lot Number 21GBQ754 ; DYNJ44599I , Lot Number 21HBU200 ; DYNJ44599I , Lot Number 21KBM267 ; DYNJ44599I , Lot Number 21LBQ208 ; DYNJ44599I , Lot Number 22NBE952 ; DYNJ44599I , Lot Number 22EBA808 ; DYNJ44599I , Lot Number 22EBV387 ; DYNJ44599I , Lot Number 22GBL830 ; DYNJ44599I , Lot Number 22HBM625 ; DYNJ44599I , Lot Number 22IBN180 ; DYNJ44599I , Lot Number 22JBH998 ; DYNJ44599I , Lot Number 22JBX287 ; DYNJ44599I , Lot Number 23ABJ748 ; DYNJ44599I , Lot Number 23BBO863 ; DYNJ44599I , Lot Number 23CBU289 ; DYNJ44599I , Lot Number 23DBO841 ; DYNJ44599I , Lot Number 23EBP969 ; DYNJ44599I , Lot Number 23GBG623 ; DYNJ44599I , Lot Number 23HBR164 ; DYNJ44599I , Lot Number 20EBC852 ; DYNJ44599I , Lot Number 23IBU633 ; DYNJ44599I , Lot Number 20FBO439 ; DYNJ44599I , Lot Number 20GBA511 ; DYNJ44599I , Lot Number 23KBI875 ; DYNJ44599I , Lot Number 24ABA732 ; DYNJ44599I , Lot Number 20JBA956 ; DYNJ44599I , Lot Number 20JBZ002 ; DYNJ44599I , Lot Number 20KBD800 ; DYNJ44599I , Lot Number 20LBI387 ; DYNJ44599I , Lot Number 21CBN891 ; DYNJ44599I , Lot Number 21CBX162 ; DYNJ66416, Lot Number 20GKA807 ; DYNJ68767, Lot Number 21HLA622 ; DYNJ68767, Lot Number 21KLA137 ; DYNJ68767, Lot Number 21LLA666 ; DYNJ68767, Lot Number 22BLA542 ; DYNJ68767, Lot Number 22DLB131 ; DYNJ68767, Lot Number 22HLA449 ; DYNJ68767, Lot Number 22ILA208 ; DYNJ68767, Lot Number 22KLA881 ; DYNJ68767, Lot Number 23ALA469 ; DYNJ68767, Lot Number 23BLA292 ; DYNJ68767, Lot Number 23CLA817 ; DYNJ68767, Lot Number 23ELA407 ; DYNJ68767, Lot Number 23ELA587 ; DYNJ68767, Lot Number 23KLA248 ; DYNJ68767, Lot Number 23LLA473 ; P737057, Lot Number 21VBC482
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.