—#208585

Product

Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

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 #208585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.