MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
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: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
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 10889942046126 (each)Model 40889942046127 (case)Model Lot Numbers: 25JMK709Model 25FMJ661Model 25CMG042Model 24IME549Model 24GMD004Model 24CMF091Model 24CME465Model 24BMH490.UPC 10889942046126UPC 40889942046127Would you have heard about this one?
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