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-
FDA device recall Z-1946-2014 · posted 2014-06-30 · Terminated
Recall details
- Recalling firm
- ORIGIO, Inc
- Reason for recall
- Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
- Action taken
- Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MQK
- Quantity affected
- 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
- Date initiated
- 2014-06-20
- Date posted
- 2014-06-30
- Date terminated
- 2015-07-20
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 (K000915) | Humagen Fertility Diagnostics, Inc. | 2000-05-12 |