Recall Z-0657-05 ยท FZP Clip, Implantable
Ethicon Endo-Surgery
ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box.
| Date | Mar 25, 2005 (initiated Feb 28, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The recalling firm sent a letter, dated 2/28/05 to consignees. |
| Quantity | 7968 devices. |
| 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 Rico, Spain, Japan, China, Republic of Singapore, Argentina, Italy, New Zealand, Australia, Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812323 | PDS* ABSORBABLE LIGATING CLIPS ETHICON, Inc., Nov 16, 1981 |