Recall Z-3012-2024
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) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ; 5) ENDO KIT, Pack Number DYKE1696 ; 6) PULMONARY ENDO KIT, Pack Number DYKE1713 ; 7) ENDO KIT, Pack Number DYKE1739 ; 8) ENDOSCOPY PACK-LF , Pack Number DYNJ00339K ; 9) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ0190667K ; 10) CH UMBIL CATH W/INSTR PACK-LF, Pack Number DYNJ0622040Q; 11) ENDOSCOPY-LF, Pack Number DYNJ22890M ; 12) ENDOSCOPIC PACK , Pack Number DYNJ30434I ; 13) ENDOSCOPIC SINUS PACK , Pack Number DYNJ40644A ; 14) ENDOSCOPY PACK, Pack Number DYNJ40645B; 15) ENDO SURGICAL PACK WRO-LF , Pack Number DYNJ41870B ; 16) ENT PK 1008847, Pack Number DYNJ42319C ; 17) ENDOVENOUS BASIC PACK , Pack Number DYNJ42456D ; 18) UROLOGY ENDOSCOPE PACK 319738 , Pack Number DYNJ44638C ; 19) ENDOSCOPY PACK-LF , Pack Number DYNJ53271C ; 20) ENDOSCOPY , Pack Number DYNJ62133; 21) ENDOSCOPY PACK, Pack Number DYNJ62193; 22) ENDOVENOUS CORE PACK, Pack Number DYNJ62557; 23) ENDOSCOPY PACK, Pack Number DYNJ62914; 24) ENDOSCOPIC PACK , Pack Number DYNJ63797A ; 25) ENDOVENOUS ABLATION PACK, Pack Number DYNJ64059; 26) GENERAL ENDOSCOPY PACK, Pack Number DYNJ65371; 27) GYN ENDOSCOPY PACK, Pack Number DYNJ65372; 28) CV NEONATAL PACK, Pack Number DYNJ67356; 29) PEDI ENDO LAP PACK, Pack Number DYNJ68141A ; 30) ENSEMBLE CATHETER DIALYSE-LF, Pack Number DYNJ81973; 31) ENT , Pack Number DYNJ900282I; 32) MUH ENDOCRINE , Pack Number DYNJ901706J; 33) SEPTO/ENDO, Pack Number DYNJ902831D; 34) MODULE ENDO LAP , Pack Number DYNJ903026I; 35) CVOR ENDOSTENT, Pack Number DYNJ906465 ; 36) ENDOSCOPIC SKULL BASE , Pack Number DYNJ906630 ; 37) ENDO CHOLE TRAY , Pack Number LZ7759N; 38) CATHETERIZATION TRAY, Pack Number UVT1175; 39) UMBILICAL VESSEL INSERTION TRA, Pack Number UVT730; 40) TVS4000 ENDOVENOUS PACK, Pack Number TVS4000K
Codes / lots: CDS984155G , Lot Number 21GBT672 ; CDS984155G , Lot Number 21JBH429 ; CDS984155G , Lot Number 21LBP590 ; CDS984155G , Lot Number 22CBJ567 ; CDS984155G , Lot Number 22FBB170 ; CDS984155G , Lot Number 22GBB172 ; CDS984155G , Lot Number 22GBW487 ; CDS984155G , Lot Number 22HBN079 ; CDS984155G , Lot Number 22IBR934 ; CDS984155G , Lot Number 19LBO258 ; CDS984155G , Lot Number 20BBE301 ; CDS984155G , Lot Number 20EBC706 ; CDS984155G , Lot Number 20EBS188 ; CDS984155G , Lot Number 20GBA894 ; CDS984155G , Lot Number 20IBD347 ; CDS984155G , Lot Number 20JBK812 ; CDS984155G , Lot Number 21BBO717 ; CDS984155G , Lot Number 21EBO578 ; DYKE1455B, Lot Number 20GBI602 ; DYKE1487C, Lot Number 22GMD695 ; DYKE1634 , Lot Number 19DAA540 ; DYKE1634 , Lot Number 19DAB449 ; DYKE1634 , Lot Number 19JAA076 ; DYKE1634 , Lot Number 21LBY138 ; DYKE1634 , Lot Number 22ABW321 ; DYKE1634 , Lot Number 22IBN133 ; DYKE1634 , Lot Number 23ABN492 ; DYKE1634 , Lot Number 23EBE760 ; DYKE1634 , Lot Number 20BBY787 ; DYKE1634 , Lot Number 23FBP558 ; DYKE1634 , Lot Number 20EBI139 ; DYKE1634 , Lot Number 23KBU935 ; DYKE1634 , Lot Number 20HBM035 ; DYKE1634 , Lot Number 20IBS530 ; DYKE1634 , Lot Number 20JBF837…
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-3012-2024
- Initiated
- April 8, 2024
- Posted by FDA
- September 6, 2024
- Product code
- PPB – Foley Catheter Kit (Excludes Hiv Testing)
- 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-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 |