Recall Z-0593-2009 ยท MQE Needle, Assisted Reproduction
Irvine Scientific Sales Co Inc
Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.
| Date | Dec 22, 2008 (initiated Oct 23, 2008) |
| Status | Terminated |
| Reason | Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip. |
| Root cause | Packaging |
| Action | The recall was initiated by Smiths Medical on October 22, 2008 with the forwarding a recall notification to Irvine Scientific. Smiths Medical International sells the products to Irvine Scientific for distribution in the U.S. Irvine Scientific is the U.S. Agent. Irvine Scientific issued an Urgent Field Safety Notice Letter, dated 10/22/2008, with attached fax-back Customer Response form to their customers via US Postal service beginning on October 24, 2008. Irvine Scientific requested their customers to complete an inventory summary on the Customer Response form and contact the firm to arran |
| Quantity | 71 units |
| Distribution | Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT. |
| FDA record | Open on fda.gov |