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U.S. Department of Health and Human Services

Class 2 Device Recall Wallace Occyte Recovery Needles, Oocyte Recovery sets

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  Class 2 Device Recall Wallace Occyte Recovery Needles, Oocyte Recovery sets see related information
Date Initiated by Firm October 23, 2008
Date Posted December 22, 2008
Recall Status1 Terminated 3 on September 02, 2011
Recall Number Z-0593-2009
Recall Event ID 50108
510(K)Number K000628  K012068  
Product Classification Assisted Reproduction Needle - Product Code MQE
Product Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: K¿LN-750, and K¿LN-750.

Retrieval of Oocytes.
Code Information Lot Number: 1270648, exp: 02/10/2013; 1281024, exp: 02/04/2013; and 1284914, exp: 03/11/2013.
Recalling Firm/
Manufacturer		 Irvine Scientific Sales Co Inc
2511 Daimler St
Santa Ana CA 92705
For Additional Information Contact
949-261-7800
Manufacturer Reason
for Recall		 Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQE and Original Applicant = SIMS PORTEX LTD.
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