MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, 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: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, 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 40198459157029 (case)Model Lot Number 25HBR321Model Lot Number 25GBD202Model Lot Number 25FBK813Model Lot Number 25EBG207Model 40195327193455 (case)Model Lot Number 23FBK499Model Lot Number 23EBV071Model Lot Number 22KBK089Model Lot Number 22IBV707Model Lot Number 22HBC310Model 40195327451654 (case)Model Lot Number 26DMG168Model Lot Number 26CMD637Model Lot Number 25KMC849UPC 10198459157028UPC 40198459157029UPC 10195327193454UPC 40195327193455UPC 10195327451653UPC 40195327451654Would you have heard about this one?
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