Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.
FDA Recall Z-0593-2009 · Posted 2008-12-22
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Recalling FirmIrvine Scientific Sales Co Inc
Recall StatusTerminated
Product CodeMQE
Date Initiated2008-10-23
Date Terminated2011-09-02
Product Quantity71 units
Reason for Recall
Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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