MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the 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 BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the 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 40193489684026 (case)Model Lot Number 22CMD618Model 40195327242399 (case)Model Lot Number 23BBK690Model Lot Number 23ABK356Model Lot Number 23ABG037Model Lot Number 22IBL708Model 40195327350728 (case)Model Lot Number 24GBK706Model Lot Number 24GBH415Model Lot Number 24FBQ282Model Lot Number 24FBC513Model Lot Number 23KBK097Model Lot Number 23DBF286Model Lot Number 23CBI425Model 40198459575656 (case)UPC 10193489684025UPC 40193489684026UPC 10195327242398UPC 40195327242399UPC 10195327350727UPC 40195327350728UPC 10198459575655Would you have heard about this one?
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