MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of 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: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 40653160327135 (case)Model Lot Number 22FBM309Model Lot Number 22DBJ094Model Lot Number 22OBH091Model Lot Number 21HBC428Model 40195327207084 (case)Model Lot Number 24ABC426Model Lot Number 23JBM836Model Lot Number 23HBS357Model Lot Number 22KBS784Model Lot Number 22IBV574Model 40195327689101 (case)Model Lot Number 26ABH211Model Lot Number 25GBS702Model Lot Number 25EBT418UPC 10653160327134UPC 40653160327135UPC 10195327207083UPC 40195327207084UPC 10195327689100UPC 40195327689101Would you have heard about this one?
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