Z-0593-2009

Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number...

Name: Z-0593-2009 Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number...
Creator: Irvine Scientific Sales Co Inc
Published: 2008-10-23
License: https://open.fda.gov/license/

FUJIFILM Biosciences Inc. / initiated 2008-10-23 / Terminated / root cause: packaging

FDA source

Irvine Scientific Sales Co Inc began a recall of Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes on 2008-10-23. The reason FDA records is "Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0593-2009
Status: Terminated
Initiated: 2008-10-23
Posted: 2008-12-22
Terminated: 2011-09-02
Recalling firm: FUJIFILM Biosciences Inc.
Product: Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.
Product code: MQE Needle, Assisted Reproduction
Reason for recall: Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
Root cause tag: packaging
FDA 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 arrange for the return of any remaining product in their inventory to the firm.
Quantity in commerce: 71 units
Distribution: Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT.
Product codes and lots: Lot Number: 1270648, exp: 02/10/2013; 1281024, exp: 02/04/2013; and 1284914, exp: 03/11/2013.

Product code MQE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)