Recall Z-3007-2024

MEDLINE INDUSTRIES, LP - Northfield · initiated April 8, 2024

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number DYNDC3274; 6) MYELOGRAM TRAY, Pack Number DYNDH1531; 7) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 8) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 9) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 10) LUMBAR PUNCTURE TRAY, Pack Number PT215; 11) FINE LACERATION KIT, Pack Number SUT19360

Codes / lots: CVI4830A, Lot Number 2022072850; CVI4835, Lot Number 2022061350; CVI4835, Lot Number 2022072850; CVI4835, Lot Number 2023111490; CVI4835, Lot Number 2023112790; DT18185, Lot Number 23EBS508 ; DT18185, Lot Number 23FBU960 ; DT18185, Lot Number 23HBQ339 ; DT22005, Lot Number 21JBI227 ; DYNDC3274, Lot Number 2022111490; DYNDC3274, Lot Number 2023101190; DYNDC3274, Lot Number 2023112790; DYNDH1531, Lot Number 2022111490; DYNJTS4301, Lot Number 2022061350; DYNJTS4301, Lot Number 2022061350; DYNJTS4306, Lot Number 2022061350; DYNJTS8100, Lot Number 2022061350; PT215, Lot Number 2022061350; SUT19360, Lot Number 2022111490

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 taken

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.

Details

Recall number
Z-3007-2024
Initiated
April 8, 2024
Posted by FDA
September 6, 2024
Product code
FKG – Tray, Start/Stop (Including Contents), Dialysis
Distribution
Worldwide distribution.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2981-2024 Class IIMedline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2982-2024 Class IIMedline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2983-2024 Class IIMedline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2984-2024 Class IIMedline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2985-2024 Class IIMedline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2986-2024 Class IIMedline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2987-2024 Class IIMedline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2988-2024 Class IIMedline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2989-2024 Class IIMedline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2990-2024 Class IIMedline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2991-2024 Class IIMedline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2992-2024 Class IIMedline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2993-2024 Class IIMedline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2994-2024 Class IIMedline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2995-2024 Class IIMedline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2)…XXX 04/08/2024Open, Classified
Z-2996-2024 Class IIMedline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2997-2024 Class IIMedline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2998-2024 Class IIMedline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-2999-2024 Class IIMedline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3000-2024 Class IIMedline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427CMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3001-2024 Class IIMedline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3002-2024 Class IIMedline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD &…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3003-2024 Class IIMedline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3004-2024 Class IIMedline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3005-2024 Class IIMedline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3006-2024 Class IIMedline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3008-2024 Class IIMedline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309IMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3009-2024 Class IIMedline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3010-2024 Class IIMedline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified
Z-3011-2024 Class IIMedline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… 04/08/2024Open, Classified