Z-2178-2008

Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is...

Name: Z-2178-2008 Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is...
Creator: Cook Vascular Inc.
Published: 2007-12-17
License: https://open.fda.gov/license/

Cook Vandergrift, Inc. / initiated 2007-12-17 / Terminated / root cause: manufacturing process

FDA source

Cook Vascular Inc. began a recall of 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... on 2007-12-17. The reason FDA records is "mislabeled - 300 micron flexipets were labeled as 80 microns". 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-2178-2008
Status: Terminated
Initiated: 2007-12-17
Posted: 2008-09-16
Terminated: 2008-09-16
Recalling firm: Cook Vandergrift, 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.
Product code: MQH Microtools, Assisted Reproduction (Pipettes)
Reason for recall: mislabeled - 300 micron flexipets were labeled as 80 microns
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Lot number 72169

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)