MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808
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: DR FERNANDEZ, Medline kit number/SKU DYNJ68808
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 10193489843187 (each)Model 40193489843188 (case)Model Lot Numbers: 21LBT965Model 21IBU081Model 21GBN159Model 21DBC976.UPC 10193489843187UPC 40193489843188Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.