Recall Z-2999-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated April 8, 2024
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) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number DYNJ17477G ; 6) ORAL SURGERY PACK-LF, Pack Number DYNJ20491N ; 7) DENTAL PACK-LF, Pack Number DYNJ36724C ; 8) DENTAL PACK WRM-LF, Pack Number DYNJ41963C ; 9) DENTAL SURGICOUNT , Pack Number DYNJ45540D ; 10) DENTAL PACK , Pack Number DYNJ49021F ; 11) DENTAL PACK , Pack Number DYNJ49021G ; 12) EXTRACTION PACK , Pack Number DYNJ49329F ; 13) CSC-N ORAL SURGERY PACK , Pack Number DYNJ50873B ; 14) ORAL SURGERY PACK , Pack Number DYNJ52404D ; 15) ORAL SURGERY PACK , Pack Number DYNJ52404F ; 16) ORAL SURGERY PACK , Pack Number DYNJ52404G ; 17) ORAL SURGERY PK RFID, Pack Number DYNJ52404I ; 18) WCMC PEDS DENTAL PACK , Pack Number DYNJ56307A ; 19) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157A ; 20) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157B ; 21) SURGERY KIT , Pack Number DYNJ58158A ; 22) SURGERY KIT , Pack Number DYNJ58158B ; 23) ORL PACK, Pack Number DYNJ59073B ; 24) ORAL SURGERY, Pack Number DYNJ59941B ; 25) ORAL SURGERY, Pack Number DYNJ59941BH; 26) MINOR DENTAL PACK-LF, Pack Number DYNJ61727I ; 27) MINOR DENTAL PACK-LF, Pack Number DYNJ61727J ; 28) MINOR DENTAL PACK-LF, Pack Number DYNJ61727K ; 29) MINOR DENTAL PACK-LF, Pack Number DYNJ61727L ; 30) DENTAL PACK , Pack Number DYNJ62779D ; 31) DENTAL PACK , Pack Number DYNJ62779F ; 32) DENTAL PACK , Pack Number DYNJ62779G ; 33) ORAL SURGERY PACK , Pack Number DYNJ66450B ; 34) ORAL PACK NTX , Pack Number DYNJ68506C ; 35) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226A ; 36) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226B ; 37) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226C ; 38) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226D ; 39) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226DH; 40) DENTAL PACK , Pack Number DYNJ80375; 41) ORAL SURGERY PACK , Pack Number DYNJ80619; 42) ORAL SURGERY PACK , Pack Number DYNJ80619A ; 43) DEAN DENTAL PACK, Pack Number DYNJ80644; 44) DEAN DENTAL PACK, Pack Number DYNJ80644A ; 45) DENTAL MINOR PACK , Pack Number DYNJ83140; 46) DENTAL PACK , Pack Number DYNJ84533; 47) ORAL SURGERY PACK-LF, Pack Number DYNJ84849; 48) ORAL, Pack Number DYNJ902377G; 49) ORAL SURGERY PACK-LF, Pack Number DYNJ904595D; 50) NYGH-MAJOR DENTAL-LF, Pack Number DYNJ905540F; 51) NYGH-MINOR DENTAL-PLASTIC-LF, Pack Number DYNJ905551C; 52) NORTH DENTAL, Pack Number DYNJ906941B; 53) ORAL, Pack Number DYNJ908371 ; 54) ORAL, Pack Number DYNJ908371A; 55) ORAL, Pack Number DYNJ908371B; 56) ORAL, Pack Number DYNJ908371C; 57) DENTAL, Pack Number DYNJ909635 ; 58) DENTAL, Pack Number DYNJ909635A
Codes / lots: CDS983010J ; Lot Number 22BBC009 ; CDS983010J ; Lot Number 22IBC611 ; CDS983010J ; Lot Number 22IBT150 ; CDS983010J ; Lot Number 22JBR866 ; CDS983010J ; Lot Number 23BBA121 ; CDS983010J ; Lot Number 23GBD710 ; CDS983010J ; Lot Number 23IBK805 ; CDS983010J ; Lot Number 23IBW114 ; CDS983010J ; Lot Number 23LMH952 ; DYNJ00354K ; Lot Number 23GMD230 ; DYNJ00354K ; Lot Number 23HMI535 ; DYNJ00354K ; Lot Number 23LMC320 ; DYNJ00354K ; Lot Number 23LMH116 ; DYNJ0426048L ; Lot Number 21FLA383 ; DYNJ0426048L ; Lot Number 21GLA406 ; DYNJ0426048L ; Lot Number 21GLB217 ; DYNJ0426048L ; Lot Number 21ILA230 ; DYNJ0426048L ; Lot Number 21JLA322 ; DYNJ0426048L ; Lot Number 21KLA413 ; DYNJ17477F ; Lot Number 22OBL759 ; DYNJ17477F ; Lot Number 22DBE452 ; DYNJ17477F ; Lot Number 22EBP359 ; DYNJ17477F ; Lot Number 22GBA339 ; DYNJ17477F ; Lot Number 22GBK261 ; DYNJ17477F ; Lot Number 22GBS374 ; DYNJ17477F ; Lot Number 22GBU600 ; DYNJ17477G ; Lot Number 22LBE020 ; DYNJ17477G ; Lot Number 23ABO736 ; DYNJ17477G ; Lot Number 23BBP921 ; DYNJ17477G ; Lot Number 23CBV133 ; DYNJ17477G ; Lot Number 23EBI573 ; DYNJ17477G ; Lot Number 23FBB745 ; DYNJ17477G ; Lot Number 23GBR631 ; DYNJ17477G ; Lot Number…
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-2999-2024
- Initiated
- April 8, 2024
- Posted by FDA
- September 6, 2024
- Product code
- OFX – General Purpose Dental Tray
- Distribution
- Worldwide distribution.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2981-2024 Class II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2)…XXX | 04/08/2024Open, Classified |
| Z-2996-2024 Class II | Medline 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 II | Medline 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 II | Medline 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-3000-2024 Class II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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-3007-2024 Class II | Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2)…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 II | Medline 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 II | Medline 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 II | Medline 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 II | Medline 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 |