FDA Medical Device Recalls (openFDA)
Cook Vascular Inc.: 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 number
- Z-2176-2008
- Recalling firm
- Cook Vascular Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-03-02
- Posted
- 2008-09-18
- Terminated
- 2008-09-18
- Reason
- mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
- Root cause
- Employee error
- 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.
- Quantity
- 100 boxes
- Distribution
- The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
- Lot, serial or model codes
- Lot number N74091
- 510(k) numbers
- ["K983596"]
- PMA numbers
- not on file
- Product code
- MQH
- Firm FEI
- 2522007
- Firm city
- Vandergrift
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28