FDA Medical Device Recalls (openFDA)
Cook Vascular Inc.: Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.
- Recall number
- Z-2178-2008
- Recalling firm
- Cook Vascular Inc.
- Product
- Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.
- Status
- Terminated
- Initiated
- 2007-12-17
- Posted
- 2008-09-16
- Terminated
- 2008-09-16
- Reason
- mislabeled - 300 micron flexipets were labeled as 80 microns
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 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
- Lot, serial or model codes
- Lot number 72169
- 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