Recall Z-2177-2008
Cook Vascular Inc. · initiated March 2, 2008
Product
Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.
Codes / lots: Lot number N74173
Reason for recall
mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-2177-2008
- Initiated
- March 2, 2008
- Posted by FDA
- September 18, 2008
- Terminated
- September 18, 2008
- Product code
- MQH – Microtools, Assisted Reproduction (Pipettes)
- Quantity
- 120 boxes
- Distribution
- The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
- Recalling firm
- Cook Vascular Inc., Vandergrift, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2176-2008 | Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The…mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | 03/02/2008Terminated |