Z-0844-2007
Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000
Merit Medical Systems, Inc. / initiated 2007-04-17 / Terminated
Merit Medical Systems, Inc. began a recall of Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000 on . The reason FDA records is "Male luer in fluid administration sets may crack due to inadequate molding process". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0844-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000.
- Product code
- FMG Stopcock, I.V. Set
- Reason for recall
- Male luer in fluid administration sets may crack due to inadequate molding process
- FDA root cause
- Other
- Action
- Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.
- Quantity in commerce
- 40,000 units
- Distribution
- CA, IL, NJ, NY. No military, government or foreign distribution.
- Product codes and lots
- Lot Number F28005.
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