Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the
FDA device recall Z-2178-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Cook Vascular Inc.
- Reason for recall
- mislabeled - 300 micron flexipets were labeled as 80 microns
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MQH
- Quantity affected
- 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
- Date initiated
- 2007-12-17
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-16
- 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 |