Z-2176-2008

Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the...

Name: Z-2176-2008 Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the...
Creator: Cook Vascular Inc.
Published: 2008-03-02
License: https://open.fda.gov/license/

Cook Vandergrift, Inc. / initiated 2008-03-02 / Terminated / root cause: manufacturing process

FDA source

Cook Vascular Inc. began a recall of 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 on 2008-03-02. The reason FDA records is "mislabeled - 300 micron flexipets labeled as 130 micron and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2176-2008
Status: Terminated
Initiated: 2008-03-02
Posted: 2008-09-18
Terminated: 2008-09-18
Recalling firm: Cook Vandergrift, 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.
Product code: MQH Microtools, Assisted Reproduction (Pipettes)
Reason for recall: mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
Root cause tag: manufacturing process
FDA 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 in commerce: 100 boxes
Distribution: The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
Product codes and lots: Lot number N74091

Product code MQH

K983596Class IIIntracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted HatchingCook Ob/Gyn / cleared 1999-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)