Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063.
FDA device recall Z-0710-2007 · posted 2007-04-04 · Terminated
Recall details
- Recalling firm
- Coloplast Corp Skin Care Div
- Reason for recall
- Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
- Action taken
- The initial consignees of the product were contacted and notified of the recall February 14, 2007. The consignees were asked to contact their customers immediately and return all product to the manufacturer.
- Root cause
- Other
- Status
- Terminated
- Product code
- KMF
- Quantity affected
- 654 boxes, 12 bottles per box for a total of 7,848 bottles
- Distribution
- Nationwide.
- Date initiated
- 2007-02-14
- Date posted
- 2007-04-04
- Date terminated
- 2007-06-25
- Location
- North Mankato, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMFEEL SEASORB DRESSING (K983519) | Coloplast Corp. | 1998-12-30 |