Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT
FDA device recall Z-1229-2007 · posted 2007-09-20 · Terminated
Recall details
- Recalling firm
- C.R. Bard Access Systems, Inc
- Reason for recall
- Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.
- Action taken
- Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.
- Root cause
- Other
- Status
- Terminated
- Product code
- MPB
- Quantity affected
- 7225 units
- Distribution
- Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).
- Date initiated
- 2007-08-10
- Date posted
- 2007-09-20
- Date terminated
- 2008-04-25
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
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| VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA (K844433) | Vas-Cath of Canada , Ltd. | 1985-03-13 |