Medline Convenience kits labeled as: 1) ECMO INSERTION recall
Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE…
Why was Medline Convenience kits labeled as: 1) ECMO INSERTION recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Distribution
- Worldwide distribution.
- Recall date
- September 18, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)