FDA Medical Device Recalls (openFDA)
Irvine Scientific Sales Co Inc: Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.
- Recall number
- Z-0593-2009
- Recalling firm
- Irvine Scientific Sales Co 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.
- Status
- Terminated
- Initiated
- 2008-10-23
- Posted
- 2008-12-22
- Terminated
- 2011-09-02
- Reason
- Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
- 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
- 71 units
- Distribution
- Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT.
- Lot, serial or model codes
- Lot Number: 1270648, exp: 02/10/2013; 1281024, exp: 02/04/2013; and 1284914, exp: 03/11/2013.
- 510(k) numbers
- K000628, K012068
- PMA numbers
- not on file
- Product code
- MQE
- Firm FEI
- 2022379
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28