Assorted non- sterile Tracecarts (with sterile component(s)); DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile,
FDA device recall Z-1205-2007 · posted 2007-08-29 · Terminated
Recall details
- Recalling firm
- DeRoyal Lafollette
- Reason for recall
- Packaging failure. Lack of sterility assurance
- Action taken
- Written notification of the recall was sent (via UPS Ground) beginning 7/03/2007 to consignees to advise them of problem and the recall. The letter stated that the recall was to the User level (which in this case, are the hospitals) and requested return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDD
- Quantity affected
- 112 cases
- Distribution
- Nationwide
- Date initiated
- 2007-07-03
- Date posted
- 2007-08-29
- Date terminated
- 2008-06-12
- Location
- La Follette, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.