Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.
This recall has been terminated (originally issued December 22, 2008).
- Company
- Irvine Scientific Sales Co Inc
- Recall Initiated
- October 23, 2008
- Posted
- December 22, 2008
- Terminated
- September 2, 2011
- Recall Number
- Z-0593-2009
- Quantity
- 71 units
- Firm Location
- Santa Ana, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
Distribution
Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT.
Lot / Code Info
Lot Number: 1270648, exp: 02/10/2013; 1281024, exp: 02/04/2013; and 1284914, exp: 03/11/2013.
Root Cause
Packaging
Action Taken
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.