Recall Z-1220-2007 ยท MQK Labware, Assisted Reproduction
Humagen Fertility Diagnostics, Inc.
IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***
| Date | Sep 18, 2007 (initiated May 8, 2007) |
| Status | Terminated |
| Reason | Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated. |
| Root cause | Other |
| Action | The recalling firm notified consignees by phone and e-mail on 05/07/07. International consignees were advised to discard product for replacement. |
| Quantity | 160 boxes |
| Distribution | The recalled product was distributed to 2 direct accounts in IL and to 6 international distributors in United Kingdom, Greece, Australia, United Arab Emirates, the Netherlands, and Israel. |
| 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 |