Recall Z-3001-2024
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) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTINOSCOPY PACK-LF , Pack Number DYNJ0796243F ; 6) RHINOPLASTY PACK, Pack Number DYNJ27333F ; 7) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384C ; 8) OSC OTOLOGY PACK-LF , Pack Number DYNJ37384D ; 9) RHINO PACK, Pack Number DYNJ46504A ; 10) RHINO PACK, Pack Number DYNJ46504B ; 11) MEDIASTINOSCOPY TEGH-LF , Pack Number DYNJ46741B ; 12) PACEMAKER PACK, Pack Number DYNJ49787A ; 13) NASAL AND SINUS PACK, Pack Number DYNJ50425A ; 14) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677A ; 15) MSC SEPTO RHINO PACK-LF , Pack Number DYNJ51677B ; 16) SEPTO RHINO PACK, Pack Number DYNJ53076C ; 17) PLASTIC ENT PACK - NTSC , Pack Number DYNJ54901A ; 18) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955B ; 19) RHINO/SEPTO/FESS PACK , Pack Number DYNJ55955C ; 20) MEDIASTINOSCOPY PACK, Pack Number DYNJ60872B ; 21) NOSE ESC, Pack Number DYNJ62371A ; 22) NASAL PACK, Pack Number DYNJ67789A ; 23) LOU MAJOR ENT , Pack Number DYNJ901851D; 24) LOU MINOR ENT , Pack Number DYNJ901852C; 25) RHYZOTOMY , Pack Number DYNJ902288G; 26) CHS NASAL AND SINUS PACK, Pack Number DYNJCH501
Codes / lots: CDS983173G , Lot Number 21FBQ527 ; CDS983173G , Lot Number 21HBF657 ; CDS983173G , Lot Number 21IBE910 ; CDS983173G , Lot Number 21IBM809 ; CDS983173G , Lot Number 21JBJ185 ; CDS983173G , Lot Number 21KBM498 ; CDS983173G , Lot Number 22ABF773 ; CDS983173G , Lot Number 22BBH011 ; CDS983173G , Lot Number 19ABX210 ; CDS983173G , Lot Number 22OBM500 ; CDS983173G , Lot Number 22EBQ566 ; CDS983173G , Lot Number 19GBS147 ; CDS983173G , Lot Number 19IBG146 ; CDS983173G , Lot Number 19IBJ785 ; CDS983173G , Lot Number 19KBA219 ; CDS983173G , Lot Number 19KBA926 ; CDS983173G , Lot Number 20BBA113 ; CDS983173G , Lot Number 20CBP609 ; CDS983173G , Lot Number 20DBU576 ; CDS983173G , Lot Number 20HBQ718 ; CDS983173G , Lot Number 20KBY137 ; CDS983173G , Lot Number 20LBL243 ; CDS983173G , Lot Number 21BBO662 ; CDS983173G , Lot Number 21EBC912 ; CDS983181D , Lot Number 21FBP606 ; CDS983181D , Lot Number 21FBP608 ; CDS983181D , Lot Number 21GBM695 ; CDS983181D , Lot Number 21IBW768 ; CDS983181D , Lot Number 21KBT227 ; CDS983181D , Lot Number 21KBT228 ; CDS983181D , Lot Number 22ABD357 ; CDS983181D , Lot Number 19ABU206 ; CDS983181D , Lot Number 19BBQ372 ; CDS983181D , Lot Number 19CBK097…
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-3001-2024
- Initiated
- April 8, 2024
- Posted by FDA
- September 6, 2024
- Product code
- MMO – Tray, Surgical, Ent
- 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-2999-2024 Class II | Medline 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 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-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 |