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U.S. Department of Health and Human Services

Class 2 Device Recall Pasteur Pipets

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  Class 2 Device Recall Pasteur Pipets see related information
Date Initiated by Firm June 20, 2014
Date Posted June 30, 2014
Recall Status1 Terminated 3 on July 20, 2015
Recall Number Z-1946-2014
Recall Event ID 68592
510(K)Number K000915  
Product Classification pipets for IVF - 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 VA 22911-7930
For Additional Information Contact
434-979-4000
Manufacturer Reason
for Recall		 Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
FDA Determined
Cause 2		 Package 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 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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