Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 a
FDA device recall Z-0357-2007 · posted 2007-01-18 · Terminated
Recall details
- Recalling firm
- Continental Medical Labs,Inc
- Reason for recall
- Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.
- Action taken
- Consignee was notified by certified mail on 10/19/06.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 840 kits
- Distribution
- Product was distributed to one consignee located in Wisconsin
- Date initiated
- 2006-10-18
- Date posted
- 2007-01-18
- Date terminated
- 2007-01-18
- Location
- Waterford, WI
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