MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
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: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI/DI 10193489820478 (each)Model 40193489820479 (case)Model Lot Numbers: 24CBL413Model 24ABX694Model 23JBY172Model 23IBI716Model 23DBG873Model 23BBR326Model 23ABH376Model 22KBS634Model 22JBS743Model 22FBT429Model 22BBZ842Model 22BBK836Model 21BBG579Model 21ABO658.UPC 10193489820478UPC 40193489820479Would you have heard about this one?
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