Recall Z-2176-2008 ยท MQH Microtools, Assisted Reproduction (Pipettes)
Cook Vascular Inc.
Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes.
| Date | Sep 18, 2008 (initiated Mar 2, 2008) |
| Status | Terminated |
| Reason | mislabeled - 300 micron flexipets labeled as 130 micron and vice versa |
| Root cause | Employee error |
| Action | The recalling firm issued an Urgent product Recall letter on 3/3/08. The letter informed the customers of the problem and that the pouch is correctly labeled. Customers were instructed to return product and notify any sub accounts. Please contact Cook Vascular at 1-724-845-8621 for assistance. |
| Quantity | 100 boxes |
| Distribution | The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING Cook Ob/Gyn, Feb 5, 1999 |