MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L; 5) RETINA LAC/USC CDS, Me
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) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L; 5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M; 6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480; 7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080; 8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 40193489980661 (case)Model Lot Number 24BBF438Model Lot Number 23LBR516Model Lot Number 23LBI385Model Lot Number 23GBW083Model Lot Number 23GBT137Model Lot Number 23GBA705Model Lot Number 23EBT206Model Lot Number 23BBN853Model Lot Number 23BBG437Model Lot Number 23BBG444Model Lot Number 23BBA852Model Lot Number 23BBA859UPC 10193489980660UPC 40193489980661Would 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.