MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC
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) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887Model (each) 40195327191888Model (case)Model Lot Number 22HMA818Model Lot Number 22GMG188Model Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764Model (each) 40195327287765Model Lot Number 23FMB021Model Lot Number 23CMB395Model Lot Number 23BMF105Model Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119Model (each) 40195327432110Model Lot Number 25BMG115UPC 10195327191887UPC 40195327191888UPC 10195327287764UPC 40195327287765UPC 10195327432119UPC 40195327432110Would you have heard about this one?
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