Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
This recall has been terminated (originally issued September 26, 2008).
- Recall Initiated
- July 14, 2008
- Posted
- September 26, 2008
- Terminated
- December 23, 2008
- Recall Number
- Z-2402-2008
- Quantity
- 690 units
- Firm Location
- West Midvale, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
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.
Lot / Code Info
Lot Number 58448226
Root Cause
Process control
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.