Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.
FDA device recall Z-2177-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Cook Vascular Inc.
- Reason for recall
- mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MQH
- Quantity affected
- 120 boxes
- Distribution
- The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
- Date initiated
- 2008-03-02
- Date posted
- 2008-09-18
- Date terminated
- 2008-09-18
- Location
- Vandergrift, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING (K983596) | Cook Ob/Gyn | 1999-02-05 |