Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY

Summary

The FDA issued a Class II for Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pa by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.

Details

Product Description

Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PACK , Pack Number DYNJ17507B ; 6) STARTER PACK CMH-LF , Pack Number DYNJ41737C ; 7) DELIVERY PACK ME-LF , Pack Number DYNJ45589B ; 8) STERILE STARTER SET PACK, Pack Number DYNJ47814; 9) IVF PACK, Pack Number DYNJ63783; 10) VI PACK , Pack Number DYNJ64811; 11) VI PACK , Pack Number DYNJ64871; 12) IR CENTRAL KIT, Pack Number DYNJ68285; 13) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0011; 14) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0012; 15) LACERATION TRAY, Pack Number SUT20955; 16) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 17) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225; 18) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225H ; 19) UMBILICAL TRAY W/3.5&5FR CATH , Pack Number UVT1250H

Lot/Code Info: CVI4915, Lot Number 2022103180; DYNDC1318D, Lot Number 2019012590; DYNJ0101308C , Lot Number 19BKC672 ; DYNJ04047C , Lot Number 21FBN548 ; DYNJ04047C , Lot Number 21GBL027 ; DYNJ04047C , Lot Number 21IBX365 ; DYNJ04047C , Lot Number 22ABM052 ; DYNJ04047C , Lot Number 19ABD460 ; DYNJ04047C , Lot Number 22CBP491 ; DYNJ04047C , Lot Number 22OBI898 ; DYNJ04047C , Lot Number 19FBD994 ; DYNJ04047C , Lot Number 22IBH860 ; DYNJ04047C , Lot Number 22IBJ054 ; DYNJ04047C , Lot Number 22LBR925 ; DYNJ04047C , Lot Number 19VBB656 ; DYNJ04047C , Lot Number 23ABS681 ; DYNJ04047C , Lot Number 19KBC727 ; DYNJ04047C , Lot Number 19KBF911 ; DYNJ04047C , Lot Number 20DBF312 ; DYNJ04047C , Lot Number 20JBC775 ; DYNJ17507B , Lot Number 19JDB044 ; DYNJ17507B , Lot Number 20EDA752 ; DYNJ17507B , Lot Number 20FDB395 ; DYNJ17507B , Lot Number 20IDB921 ; DYNJ17507B , Lot Number 20JDA956 ; DYNJ17507B , Lot Number 20LDB169 ; DYNJ17507B , Lot Number 21GDA031 ; DYNJ17507B , Lot Number 21HDB179 ; DYNJ17507B , Lot Number 21JDC732 ; DYNJ17507B , Lot Number 23ADA442 ; DYNJ41737C , Lot Number 21FBK597 ; DYNJ41737C , Lot Number 21GBM874 ; DYNJ41737C , Lot Number 21IBD142 ; DYNJ41737C , Lot Number 21JBB598 ; DYNJ41737C , Lot Number 21JBB602 ; DYNJ41737C , Lot Number 21WBA194 ; DYNJ41737C , Lot Number 21LBP147 ; DYNJ41737C , Lot Number 22ABE433 ; DYNJ41737C , Lot Number 19ABJ657 ; DYNJ41737C , Lot Number 19CBB947 ; DYNJ41737C , Lot Number 22OBI031 ; DYNJ41737C , Lot Number 19CBO914 ; DYNJ41737C , Lot Number 19DBC698 ; DYNJ41737C , Lot Number 19DBO702 ; DYNJ41737C , Lot Number 22FBJ538 ; DYNJ41737C , Lot Number 19RBC166 ; DYNJ41737C , Lot Number 22HBV259 ; DYNJ41737C , Lot Number 19SBB262 ; DYNJ41737C , Lot Number 22JBK898 ; DYNJ41737C , Lot Number 19IBB771 ; DYNJ41737C , Lot Number 19IBE072 ; DYNJ41737C , Lot Number 19JBE636 ; DYNJ41737C , Lot Number 19LBT637 ; DYNJ41737C , Lot Number 20CBC820 ; DYNJ41737C , Lot Number 23GBF976 ; DYNJ41737C , Lot Number 23HBE132 ; DYNJ41737C , Lot Number 20EBD652 ; DYNJ41737C , Lot Number 20FBN024 ; DYNJ41737C , Lot Number 23JBK069 ; DYNJ41737C , Lot Number 23LBI143 ; DYNJ41737C , Lot Number 20JBE583 ; DYNJ41737C , Lot Number 21BBS926 ; DYNJ41737C , Lot Number 21CBX913 ; DYNJ45589B , Lot Number 18LBQ229 ; DYNJ45589B , Lot Number 19BBI698 ; DYNJ45589B , Lot Number 19EBB616 ; DYNJ47814, Lot Number 19BBC131 ; DYNJ47814, Lot Number 19DBQ381 ; DYNJ47814, Lot Number 19GBA816 ; DYNJ47814, Lot Number 19IBK685 ; DYNJ47814, Lot Number 19KBJ696 ; DYNJ47814, Lot Number 19LBU531 ; DYNJ47814, Lot Number 20CBY831 ; DYNJ47814, Lot Number 20FBI187 ; DYNJ63783, Lot Number 21JBB671 ; DYNJ63783, Lot Number 21KBJ500 ; DYNJ63783, Lot Number 22BBF553 ; DYNJ63783, Lot Number 22OBI679 ; DYNJ63783, Lot Number 22EBE312 ; DYNJ63783, Lot Number 22HBM741 ; DYNJ63783, Lot Number 22IBH464 ; DYNJ63783, Lot Number 19HBB067 ; DYNJ63783, Lot Number 23DBJ842 ; DYNJ63783, Lot Number 20ABM496 ; DYNJ63783, Lot Number 23FBH844 ; DYNJ63783, Lot Number 20CBL632 ; DYNJ63783, Lot Number 23GBH242 ; DYNJ63783, Lot Number 20EBH703 ; DYNJ63783, Lot Number 23IBF782 ; DYNJ63783, Lot Number 20HBD244 ; DYNJ63783, Lot Number 20JBM648 ; DYNJ63783, Lot Number 20JBW602 ; DYNJ63783, Lot Number 20LBP393 ; DYNJ63783, Lot Number 21DBP053 ; DYNJ64811, Lot Number 19KBO216 ; DYNJ64871, Lot Number 21IBR317 ; DYNJ64871, Lot Number 21KBR802 ; DYNJ64871, Lot Number 21KBR840 ; DYNJ64871, Lot Number 22BBZ525 ; DYNJ64871, Lot Number 22EBN632 ; DYNJ64871, Lot Number 22GBV097 ; DYNJ64871, Lot Number 22LBK474 ; DYNJ64871, Lot Number 23ABB889 ; DYNJ64871, Lot Number 19KBP348 ; DYNJ64871, Lot Number 20ABR888 ; DYNJ64871, Lot Number 23EBJ477 ; DYNJ64871, Lot Number 20BBK386 ; DYNJ64871, Lot Number 23FBO926 ; DYNJ64871, Lot Number 23GBQ643 ; DYNJ64871, Lot Number 23HBM974 ; DYNJ64871, Lot Number 23KBF276 ; DYNJ64871, Lot Number 20HBN235 ; DYNJ64871, Lot Number 20KBG137 ; DYNJ64871, Lot Number 20XBF536 ; DYNJ64871, Lot Number 21BBL845 ; DYNJ68285, Lot Number 21AME264 ; PICC0011, Lot Number 2022030150; PICC0011, Lot Number 2022061090; PICC0012, Lot Number 2022022450; SUT20955, Lot Number 2019012590; UVT1100A, Lot Number 2022103180; UVT1225, Lot Number 23BBJ869 ; UVT1225, Lot Number 23DBN509 ; UVT1225H , Lot Number 23BBJ869 ; UVT1225H , Lot Number 23DBN509 ; UVT1250H , Lot Number 23IBE795 ; UVT1250H , Lot Number 23KBE411

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-04-08

Company