Recall Z-3297-2024 ยท MQL Media, Reproductive
CooperSurgical, Inc.
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
| Date | Sep 26, 2024 (initiated Feb 16, 2024) |
| Status | Open, Classified |
| Reason | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| Root cause | Under Investigation by firm |
| Action | CooperSurgical issued Urgent: Voluntary Medical Device Field Safety Notice on 2/16/24 via UPS Next Day Air via third party Sedgewick. Letter states reason for recall, health risk and action to take: 1) Inspect your inventory, quarantine any affected product, and immediately stop using the product. 2) Complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory ( or have not distr |
| Quantity | 2680 units |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash Origio A/S, Jul 22, 2016 |