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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 December 17, 2007
Date Posted September 16, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall Number Z-2178-2008
Recall Event ID 48630
510(K)Number K983596  
Product Classification Pipette - Product Code MQH
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.
Code Information Lot number 72169
Recalling Firm/
Manufacturer		 Cook Vascular Inc.
1186 Montgomery Ln
Vandergrift PA 15690-6065
For Additional Information Contact Thomas Kardos
724-845-8621 Ext. 2225
Manufacturer Reason
for Recall		 mislabeled - 300 micron flexipets were labeled as 80 microns
FDA Determined
Cause 2		 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
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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