ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200. Ten cartridges are packaged per box.
FDA device recall Z-0655-05 · posted 2005-03-25 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- Reason for recall
- The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Action taken
- The recalling firm sent a letter, dated 2/28/05 to consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- FZP
- Quantity affected
- 23,046 boxes.
- Distribution
- The product was distributed throughout the United States and to foreign customers located in Saudi Arabia, Egypt, United Kingdom, Germany, France, Republic of Panama, Turkey, Hong Kong, Taiwan, Puerto
- Date initiated
- 2005-02-28
- Date posted
- 2005-03-25
- Date terminated
- 2007-02-21
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PDS* ABSORBABLE LIGATING CLIPS (K812323) | ETHICON, Inc. | 1981-11-16 |