MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)
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 CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 40193489640459 (case)Model Lot Number 21KBV571Model 40195327193479 (case)Model Lot Number 23EBU351Model Lot Number 23DBQ190Model Lot Number 23BBE364Model Lot Number 22IBW094Model 40195327451685 (case)Model Lot Number 26CMK666Model Lot Number 26BMG709Model Lot Number 26AMI644Model Lot Number 25KMD133Model Lot Number 25JMA568Model Lot Number 25IMF717Model Lot Number 25HMJ595UPC 10193489640458UPC 40193489640459UPC 10195327193478UPC 40195327193479UPC 10195327451684UPC 40195327451685Would you have heard about this one?
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