Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3056-2024
• Recall Event ID: 94583
• Product Classification: Suture removal kit - Product Code MCZ
• Product: Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING SET, Pack Number SUT21770 ; 7) SUTURE SET, Pack Number SUT21810 ; 8) SUTURING SET, Pack Number SUT21810H; 9) SUTURE TRAY , Pack Number SUT21830
• Code Information: 59112, Lot Number 21VBA069 ; DYNDL1984, Lot Number 22IBK601 ; DYNDL1984, Lot Number 22LBA112 ; DYNDL1984, Lot Number 23CBJ757 ; DYNDL1984, Lot Number 23FBI531 ; DYNJ68267A , Lot Number 23GBW001 ; DYNJ68267A , Lot Number 23IBD069 ; MNS15015 , Lot Number 23DLA584 ; MNS15015 , Lot Number 23GLB127 ; MNS15015 , Lot Number 23ILA127 ; MNS15015 , Lot Number 23ILA978 ; MNS15015 , Lot Number 23JLA433 ; MNS15015 , Lot Number 23KLA928 ; MNS15015H, Lot Number 23DLA584 ; MNS15015H, Lot Number 23GLB127 ; MNS15015H, Lot Number 23ILA127 ; MNS15015H, Lot Number 23ILA978 ; MNS15015H, Lot Number 23JLA433 ; MNS15015H, Lot Number 23KLA928 ; SUT21770 , Lot Number 23DBI036 ; SUT21770 , Lot Number 23FBH231 ; SUT21770 , Lot Number 23GBM232 ; SUT21770 , Lot Number 23JBO236 ; SUT21770 , Lot Number 23JBP503 ; SUT21810 , Lot Number 23IBA704 ; SUT21810 , Lot Number 23JMF069 ; SUT21810 , Lot Number 23KME590 ; SUT21810H, Lot Number 23JMF069 ; SUT21810H, Lot Number 23KME590 ; SUT21810H, Lot Number 23IBA704 ; SUT21830 , Lot Number 23KBF032
• 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.