Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and
FDA device recall Z-0593-2009 · posted 2008-12-22 · Terminated
Recall details
- Recalling firm
- Irvine Scientific Sales Co Inc
- Reason for recall
- Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- MQE
- Quantity affected
- 71 units
- Distribution
- Nationwide Distribution --- including states of CA, FL, PA, IL, OR & UT.
- Date initiated
- 2008-10-23
- Date posted
- 2008-12-22
- Date terminated
- 2011-09-02
- Location
- Santa Ana, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S (K012068) | Sims Portex , Ltd. | 2001-08-03 |
| WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 (K000628) | Sims Portex , Ltd. | 2000-03-13 |