FDA Recall
Terminated
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.
Recall: Z-2176-2008
·
Initiated March 2, 2008
Recall
- Recall Number
- Z-2176-2008
- Event Number
- 48629
- Firm
- Cook Vascular Inc.
- FEI Number
- 2522007
- Product Code
- MQH
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 2, 2008
- Posted
- September 18, 2008
- Terminated
- September 18, 2008
- Address
- 1186 Montgomery Ln, Vandergrift, PA, 15690-6065
Description
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.
Reason
mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
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.
Distribution
The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
Quantity
100 boxes