Recall Z-2983-2024
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) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number DYNDA1598C; 6) INTUBATION KIT , Pack Number DYNDA1598CH ; 7) ANESTHESIA KIT , Pack Number DYNDA2958; 8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758; 9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889; 10) PEDIATRIC CARDIAC PACK-LF, Pack Number DYNJ0537013Y; 11) PEDIATRIC MINOR PK, Pack Number DYNJ49035B; 12) WMC PEDIATRIC ADD ON PACK-LF, Pack Number DYNJ50644; 13) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283B; 14) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283C; 15) AIRWAY PACK , Pack Number DYNJ60239B; 16) ANESTHESIA PAIN PK LEAGUE, Pack Number DYNJ67925; 17) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603I ; 18) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603J ; 19) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503A ; 20) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503B ; 21) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503C ; 22) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503D ; 23) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503F ; 24) #######, Pack Number DYNJ905503F ; 25) MZ MDL AIRWAY, Pack Number DYNJ910129; 26) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA10379 ; 27) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA6572; 28) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 29) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 30) REGIONAL ANESTHESIA PREP TRAY , Pack Number DYNJRA0376A ; 31) ANESTHESIA KIT , Pack Number DYNJRA0424A ; 32) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767; 33) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767A ; 34) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767B ; 35) ANESTHESIA SUPPORT TRAY , Pack Number DYNJRA0779A ; 36) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0887A ; 37) ANESTHESIA TRAY, Pack Number DYNJRA0909; 38) SPINAL ANESTHESIA TRAY/WHITE, Pack Number DYNJRA0955A ; 39) #####, Pack Number DYNJRA0955A ; 40) ANESTHESIA SUPPORT TRAY/B, Pack Number DYNJRA0968; 41) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119; 42) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119A ; 43) ANESTHESIA TRAY, Pack Number DYNJRA1355; 44) ANESTHESIA TRAY, Pack Number DYNJRA1355A ; 45) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1577A ; 46) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659; 47) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659A ; 48) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1757; 49) ANESTHESIA PREP KIT, Pack Number DYNJRA1899; 50) ANESTHESIA TRAY, Pack Number DYNJRA1934; 51) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA2087; 52) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA2151; 53) PRE OP ANES KIT, Pack Number DYNJRA2228; 54) PRE OP ANES KIT, Pack Number DYNJRA2228H; 55) CUSTOM ANESTHESIA KIT-LF, Pack Number GSP478I; 56) REGIONAL TRAY, Pack Number PAIN0385B; 57) EPIDURAL ANESTHESIA KIT , Pack Number PAIN1982 ; 58) CIRC PACK-LF, Pack Number PHS41720I; 59) CIRC PACK-LF, Pack Number PHS41720J; 60) ANES CIRC 90 EXP, Pack Number VM96DLEX2L
Codes / lots: 35772, Lot Number 19GBK969 ; 81842, Lot Number 20JBS956 ; DYKE1796 , Lot Number 21GBR139 ; DYKE1796 , Lot Number 22HBX360 ; DYKE1796 , Lot Number 22JBR572 ; DYKSCRIPPSIN4, Lot Number 19DAA326 ; DYKSCRIPPSIN4, Lot Number 19EAA345 ; DYKSCRIPPSIN4, Lot Number 19HAB271 ; DYKSCRIPPSIN4, Lot Number 19LAA719 ; DYKSCRIPPSIN4, Lot Number 20AAA102 ; DYKSCRIPPSIN4, Lot Number 20BAA611 ; DYKSCRIPPSIN4, Lot Number 20DAA064 ; DYNDA1598C , Lot Number 23KMF159 ; DYNDA1598C , Lot Number 24AMG428 ; DYNDA1598CH, Lot Number 23KMF159 ; DYNDA1598CH, Lot Number 24AMG428 ; DYNDA2958, Lot Number 22KBH750 ; DYNDH1758, Lot Number 22HBX410 ; DYNDH1758, Lot Number 22JBU749 ; DYNDH1758, Lot Number 22LBK163 ; DYNDH1889, Lot Number 23HBZ539 ; DYNDH1889, Lot Number 23KBG134 ; DYNJ0537013Y , Lot Number 21LMD783 ; DYNJ49035B , Lot Number 19BDA167 ; DYNJ49035B , Lot Number 19CDC764 ; DYNJ49035B , Lot Number 19EDD455 ; DYNJ49035B , Lot Number 19GDC256 ; DYNJ49035B , Lot Number 19IDC024 ; DYNJ49035B , Lot Number 20ADA825 ; DYNJ49035B , Lot Number 20BDC864 ; DYNJ49035B , Lot Number 20DDA660 ; DYNJ49035B , Lot Number 20GDB084 ; DYNJ49035B , Lot Number 20IDB475 ; DYNJ49035B , Lot Number 20LDA638 ; DYNJ50644, 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-2983-2024
- Initiated
- April 8, 2024
- Posted by FDA
- September 6, 2024
- Product code
- CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece)
- 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-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 |
| 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 |