Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.
FDA Recall Z-2177-2008 · Posted 2008-09-18
Recalling FirmCook Vascular Inc.
Recall StatusTerminated
Product CodeMQH
Date Initiated2008-03-02
Date Terminated2008-09-18
Product Quantity120 boxes
Reason for Recall
mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
Firm 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.
Root Cause
Employee error
Distribution Pattern
The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.