Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2178-2008 · Posted 2008-09-16

Recalling FirmCook Vascular Inc.
Recall StatusTerminated
Product CodeMQH
Date Initiated2007-12-17
Date Terminated2008-09-16
Product Quantity35 vials

Reason for Recall

mislabeled - 300 micron flexipets were labeled as 80 microns

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983596INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHINGCook Ob/Gyn · 1999-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑