Recall Z-1629-2014 ยท FRN Pump, Infusion
The Anspach Effort, Inc.
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
| Date | May 16, 2014 (initiated Dec 3, 2013) |
| Status | Terminated |
| Reason | The Irrigation Clips were assembled with the incorrect (smaller) clips. |
| Root cause | Mixed-up of materials/components |
| Action | The firm, Anspach, sent an URGENT: Medical Device Removal letter dated December 3, 2013 to its customer. The letter described the product, problem and actions to be taken. Should you have any queries, please do not hesitate to contact Aspach Customer Support at (800) 327-6887. |
| Quantity | 150 |
| Distribution | US Nationwide Distribution in the state of Mississippi. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030576 | ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II The Anspach Effort, Inc., May 21, 2003 |