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U.S. Department of Health and Human Services

Class 2 Device Recall Flexipet Manipulation pipette 300 micron

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  Class 2 Device Recall Flexipet Manipulation pipette 300 micron see related information
Date Initiated by Firm March 02, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on September 18, 2008
Recall Number Z-2177-2008
Recall Event ID 48629
510(K)Number K983596  
Product Classification Pipette - Product Code MQH
Product Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.
Code Information Lot number N74173
Recalling Firm/
Manufacturer		 Cook Vascular Inc.
1186 Montgomery Ln
Vandergrift PA 15690-6065
For Additional Information Contact Thomas Kardos
724-845-8621
Manufacturer Reason
for Recall		 mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
FDA Determined
Cause 2		 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 120 boxes
Distribution The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQH and Original Applicant = COOK OB/GYN
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