Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the woun
FDA device recall Z-1407-04 · posted 2004-08-25 · Terminated
Recall details
- Recalling firm
- Cardinal Health
- Reason for recall
- The products labeled as sterile are not sterile.
- Action taken
- The accounts were telephoned on 7/28/04 and sent follow-up letters on the same date. They were informed that affected lots of products were not sterile, and were requested to inspect their inventory and segregate the product for return to Cardinal Health. The accounts were instructed to call 800-635-6021 for product return and instructions on how to obtain credit and replacement product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBX
- Quantity affected
- 60 cases
- Distribution
- Florida, Arizona, New Jersey and Canada
- Date initiated
- 2004-07-28
- Date posted
- 2004-08-25
- Date terminated
- 2005-02-10
- Location
- McGaw Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.