MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
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: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 40195327371105 (case)Model Lot Number 23DLA834Model 40195327231133 (case)Model Lot Number 23BMC463Model Lot Number 23AMA685Model Lot Number 23AMB905Model Lot Number 22LMG466Model Lot Number 22LMB983Model 40198459228804 (case)Model Lot Number 25JBD225Model Lot Number 25HBW236.UPC 10195327371104UPC 40195327371105UPC 10195327231132UPC 40195327231133UPC 10198459228803UPC 40198459228804Would you have heard about this one?
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