Recall Z-1246-2016 ยท GDO Applier, Surgical, Clip
The Anspach Effort, Inc.
Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
| Date | Nov 2, 2015 |
| Status | Terminated |
| Reason | Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). |
| Root cause | Nonconforming Material/Component |
| Action | On Nov 2, 2015 Anspach sent a letter to their customers informing them of the recall. Customer Immediate Actions: Please complete the attached reply form confirming your receipt of this letter. Return the completed form by fax to the number or email provided on the form. Returning the form promptly will prevent you from receiving repeat notices. If you distribute any of the products to other services or facilities, please forward this information as appropriate. We understand this product recall removal) may have an impact on your facility. The FDA has recommended that healthcare facilities |
| Quantity | 50 clips |
| Distribution | Distributed in the states of PA and MN, and the country of Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.