Recall Z-1946-2014 ยท MQK Labware, Assisted Reproduction
ORIGIO, Inc
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
| Date | Jun 30, 2014 (initiated Jun 20, 2014) |
| Status | Terminated |
| Reason | Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration |
| Root cause | Package design/selection |
| Action | Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000915 | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 Humagen Fertility Diagnostics, Inc., May 12, 2000 |