High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
FDA device recall Z-1497-2011 · posted 2011-03-02 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
- Action taken
- Ethicon sent their recall letters with business reply cards attached on February 2, 2011 via UPS overnight mail. Customers are informed of the issue and asked to return the attached business reply card.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KGX
- Quantity affected
- 725,722 each (total)
- Distribution
- Worldwide distribution, including USA, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Repub, Chile, China, Denmark, Dominican Repub, Egypt, Finland, France, French Guiana, Germ
- Date initiated
- 2011-02-02
- Date posted
- 2011-03-02
- Date terminated
- 2012-11-07
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ETHICON* SKIN CLOSURE TAPE (K813124) | ETHICON, Inc. | 1981-12-08 |