Thin-Flex Venous Return Cannulae with Duraflo coating, REF DTF3343O, 33/43 Fr. x 39 cm, Sterile EO, Edwards Lifesciences
FDA device recall Z-2403-2008 · posted 2008-09-26 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Reason for recall
- Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
- Action taken
- All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 90 units
- Distribution
- Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
- Date initiated
- 2008-07-14
- Date posted
- 2008-09-26
- Date terminated
- 2008-12-23
- Location
- Midvale, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIOUS CARDIOVASCULAR SURGICAL DEVICE (K831769) | Research Industries Corp. | 1983-08-12 |