Recall Z-2178-2008 ยท MQH Microtools, Assisted Reproduction (Pipettes)
Cook Vascular Inc.
Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.
| Date | Sep 16, 2008 (initiated Dec 17, 2007) |
| Status | Terminated |
| Reason | mislabeled - 300 micron flexipets were labeled as 80 microns |
| Root cause | Employee error |
| Action | The sales representatives were notified via email on 12/14/07 of the problem. The recalling firm issued recall letters on 12/18/07 via overnight mail. The letter informed the customers of the problem and the need to return any product. The letter also instructed customers to notify any sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance. |
| Quantity | 35 vials |
| Distribution | The product was shipped to a medical facility in TN and sales reps in NJ and MD. The product was also shipped to distributors in Indonesia, Australia, and Ireland |
| 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 |