Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, 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.
FDA Recall Z-2401-2008 · Posted 2008-09-26
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Recalling FirmEdwards Lifesciences Research Medical, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2008-07-14
Date Terminated2008-12-23
Product Quantity707 units
Reason for Recall
Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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