MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
Medline Industries, LP
The hazard
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 40193489344241 (case)Model Lot Number 21ABD933Model 40193489847124 (case)Model Lot Number 22IBJ338Model Lot Number 22EBL456Model Lot Number 22EBL231Model Lot Number 22BBW955Model Lot Number 22ABC123Model Lot Number 21IBM442Model Lot Number 21IBI539Model Lot Number 21FBT730Model Lot Number 21EBA066Model Lot Number 21CBW872Model 40195327233618 (case)Model Lot Number 23HBV936UPC 10193489344240UPC 40193489344241UPC 10193489847123UPC 40193489847124UPC 10195327233617UPC 40195327233618Would you have heard about this one?
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