Device 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
Z-1946-2014
Product summary
- Firm
- ORIGIO, Inc
- Event
- Event 68592
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511
- Official record key
device-enforcement:Z-1946-2014
Official wording
Reason: Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
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.
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
packaging breach of the nylon pouch sterile