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U.S. Department of Health and Human Services

Class 2 Device Recall IVF Pasteur Pipettes

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  Class 2 Device Recall IVF Pasteur Pipettes see related information
Date Initiated by Firm May 08, 2007
Date Posted September 18, 2007
Recall Status1 Terminated 3 on October 29, 2007
Recall Number Z-1220-2007
Recall Event ID 38348
510(K)Number K000915  
Product Classification embryo transfer pipettes - Product Code MQK
Product IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***
Code Information 160306022 EXP 1/22/2010 160306046 EXP 2/15/2010 160306065 EXP 3/6/2010 
Recalling Firm/
Manufacturer		 Humagen Fertility Diagnostics, Inc.
2400 Hunters Way
Charlottesville VA 22911-7930
For Additional Information Contact Cindy Showalter
434-979-4000
Manufacturer Reason
for Recall		 Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.
FDA Determined
Cause 2		 Other
Action The recalling firm notified consignees by phone and e-mail on 05/07/07. International consignees were advised to discard product for replacement.
Quantity in Commerce 160 boxes
Distribution The recalled product was distributed to 2 direct accounts in IL and to 6 international distributors in United Kingdom, Greece, Australia, United Arab Emirates, the Netherlands, and Israel.
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 = MQK and Original Applicant = HUMAGEN FERTILITY DIAGNOSTICS, INC.
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