Recall Z-2987-2024
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) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF, Pack Number DYNJ0957053DH; 6) SINGLE SHOT TRAY, Pack Number DYNJ32736; 7) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352A ; 8) SINGLE SHOT EPIDURAL-LF , Pack Number DYNJ36046A ; 9) PHOENIXVILLE EPIDURAL TRAY, Pack Number DYNJ40991A ; 10) UNIVERSAL SCOPE PACK, Pack Number DYNJ45052A ; 11) SPINAL PACK , Pack Number DYNJ48916B ; 12) PUH SPINAL BLOCK TRAY , Pack Number DYNJ49205B ; 13) EPIDURAL PACK , Pack Number DYNJ50772A ; 14) TRANSFORAMINAL PACK , Pack Number DYNJC3420D ; 15) EPIDURAL PREP TRAY-LF , Pack Number DYNJRA0135B; 16) SUPPORT TRAY-LF, Pack Number DYNJRA0198; 17) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0245 ; 18) EPIDURAL TRAY , Pack Number DYNJRA0260 ; 19) SPINAL EPIDURAL (TUOHY) PF, Pack Number DYNJRA0270B; 20) EPIDURAL TRAY-LF, Pack Number DYNJRA0275A; 21) SPINAL BLOCK TRAY- LF , Pack Number DYNJRA0413B; 22) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number DYNJRA0506A; 23) EPIDURAL TRAY , Pack Number DYNJRA0508 ; 24) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0555 ; 25) COMBINED SPINAL/EPIDURAL PACK , Pack Number DYNJRA0635 ; 26) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA0766 ; 27) TRANSFORAMINAL 22X5PF , Pack Number DYNJRA0777F; 28) TRANSFORMINAL TRAY, Pack Number DYNJRA0822A; 29) SPINAL TRAY, Pack Number DYNJRA0836A; 30) SPINAL TRAY , Pack Number DYNJRA0978A; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0988 ; 32) TRAY, SPINAL, WHIT 24GX4, Pack Number DYNJRA1034 ; 33) TRANSFORAMINAL TRAY , Pack Number DYNJRA1730A; 34) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028 ; 35) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028H; 36) TRAY, SPINAL PENCIL POINT 25G , Pack Number DYNJRA9030 ; 37) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036 ; 38) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036H; 39) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA9037 ; 40) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0012 ; 41) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0024D; 42) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0055A; 43) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0058D; 44) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0078C; 45) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0082D; 46) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0111C; 47) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0133 ; 48) COMPLETE SINGLE SHOT TRAY , Pack Number PAIN0136A; 49) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0146C; 50) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0157G; 51) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0171C; 52) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0191I; 53) NORTON SINGLE SHOT EPIDURAL , Pack Number PAIN0215A; 54) EPIDURAL TRAY , Pack Number PAIN0225 ; 55) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0242B; 56) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0250A; 57) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0256B; 58) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0261A; 59) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0262A; 60) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0265C; 61) EPI TRAY, SINGLE , 20G-LF , Pack Number PAIN0274A; 62) EPI TRAY CONTI 17G TUOHY, Pack Number PAIN0275 ; 63) EPIDURAL TRAY-LF, Pack Number PAIN0279C; 64) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0280C; 65) SINGLE DOSE EPI-LF, Pack Number PAIN0300B; 66) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0317A; 67) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0334A; 68) EPIDURAL TRAY-LF, Pack Number PAIN0349B; 69) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0357B; 70) SHOT EPIDURAL TRAY-LF , Pack Number PAIN0362 ; 71) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0386B; 72) CONTINUOUS EPIDURAL TRAY, Pack Number PAIN0390 ; 73) SINGLE SHOT EPIDURAL T
Codes / lots: DYNJ0708470K , Lot Number 19ALA269 ; DYNJ0708470K , Lot Number 19ELA237 ; DYNJ0708470K , Lot Number 19FLA396 ; DYNJ0708470K , Lot Number 19GLA166 ; DYNJ0708470K , Lot Number 19HLA649 ; DYNJ0708470K , Lot Number 19ILA054 ; DYNJ0708470K , Lot Number 19JLA505 ; DYNJ0708470K , Lot Number 19KLA167 ; DYNJ0708470K , Lot Number 19LLA455 ; DYNJ0844004, Lot Number 19AKB795 ; DYNJ0844004, Lot Number 19DKC239 ; DYNJ0844004, Lot Number 19EKB799 ; DYNJ0844004, Lot Number 19FKB763 ; DYNJ0844004, Lot Number 19GKB309 ; DYNJ0844004, Lot Number 19HKC027 ; DYNJ0844004, Lot Number 19IKB582 ; DYNJ0844004, Lot Number 19JKB630 ; DYNJ0844004, Lot Number 19KKB713 ; DYNJ0934752F , Lot Number 20LLA127 ; DYNJ0934752F , Lot Number 21ALA602 ; DYNJ0934752F , Lot Number 21DLA714 ; DYNJ0934752F , Lot Number 21FLA405 ; DYNJ0934752F , Lot Number 21GLB256 ; DYNJ0934752F , Lot Number 21ILA246 ; DYNJ0934752F , Lot Number 21KLA976 ; DYNJ0934752F , Lot Number 22ALA019 ; DYNJ0934752F , Lot Number 22CLB255 ; DYNJ0934752F , Lot Number 22FLA066 ; DYNJ0934752F , Lot Number 22HLA808 ; DYNJ0934752F , Lot Number 23ALA905 ; DYNJ0934752F , Lot Number 23DLA487 ; DYNJ0934752F , Lot Number 23HLA233 ; DYNJ0934752F , 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-2987-2024
- Initiated
- April 8, 2024
- Posted by FDA
- September 6, 2024
- Product code
- OGE – Epidural Anesthesia Kit
- 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-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 |
| 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 |