FDA Recall Terminated

Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.

Recall: Z-0593-2009 · Initiated October 23, 2008

Recall

Recall Number
Z-0593-2009
Event Number
50108
Firm
Irvine Scientific Sales Co Inc
FEI Number
2022379
Product Code
MQE
Status
Terminated
Root Cause
Packaging
Initiated
October 23, 2008
Posted
December 22, 2008
Terminated
September 2, 2011
Address
2511 Daimler St, Santa Ana, CA, 92705

Description

Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.

Reason

Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.

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 arrange for the return of any remaining product in their inventory to the firm.

Distribution

Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT.

Quantity

71 units