| Class 2 Device Recall Pasteur Pipets | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MQK
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