Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2989-2024
• Recall Event ID: 94583
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
• Code Information: DYNJRA9026 , Lot Number 22EBN191 ; DYNJRA9026 , Lot Number 22LBC356 ; DYNJRA9026 , Lot Number 23ABN403 ; DYNJRA9026 , Lot Number 23CBP475 ; DYNJRA9026 , Lot Number 23DBG934 ; DYNJRA9026 , Lot Number 23EBH050 ; DYNJRA9026 , Lot Number 23JBS641 ; DYNJRA9026 , Lot Number 23KBJ179 ; DYNJRA9026 , Lot Number 23LBU686 ; DYNJRA9026 , Lot Number 19ADC324 ; DYNJRA9026 , Lot Number 19ADD208 ; DYNJRA9026 , Lot Number 19LDA087 ; DYNJRA9026 , Lot Number 19LDB132 ; DYNJRA9026 , Lot Number 20ADC808 ; DYNJRA9026 , Lot Number 20BDA346 ; DYNJRA9026 , Lot Number 20BDB555 ; DYNJRA9026 , Lot Number 20CDB731 ; DYNJRA9026 , Lot Number 20EDC526 ; DYNJRA9026 , Lot Number 20GDA908 ; DYNJRA9026 , Lot Number 20IDA046 ; DYNJRA9026 , Lot Number 20IDA621 ; DYNJRA9026 , Lot Number 20LDB113 ; DYNJRA9026 , Lot Number 20LDB323 ; DYNJRA9026 , Lot Number 21BDA498 ; DYNJRA9026 , Lot Number 21DDA458 ; DYNJRA9026 , Lot Number 21DDA663 ; DYNJRA9026 , Lot Number 21HDC456 ; DYNJRA9026 , Lot Number 21JDB091 ; DYNJRA9026 , Lot Number 21KDC632 ; DYNJRA9026 , Lot Number 21LDA581 ; DYNJRA9026 , Lot Number 21LDB014 ; DYNJRA9026 , Lot Number 22BDA209 ; DYNJRA9026 , Lot Number 22BDC191 ; DYNJRA9026 , Lot Number 22CDA655 ; DYNJRA9026 , Lot Number 22CDC010 ; DYNJRA9026 , Lot Number 22ILB005 ; DYNJRA9026 , Lot Number 22KLA115
• 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.