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U.S. Department of Health and Human Services

Class 2 Device Recall Pasteur Pipets

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 Class 2 Recall
Pasteur Pipets
see related information
Date Posted June 30, 2014
Recall Status1 Open
Recall Number Z-1946-2014
Recall Event ID 68592
Premarket Notification
510(K) Number
K000915 
Product Classification Labware, Assisted Reproduction - Product Code MQK
Product Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
Code Information CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.
Recalling Firm/
Manufacturer
ORIGIO, Inc
2400 Hunters Way
Charlottesville, Virginia 22911-7930
Manufacturer Reason
for Recall
Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014.
Quantity in Commerce Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511
Distribution Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQK and Original Applicant = HUMAGEN FERTILITY DIAGNOSTICS, INC.
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