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Terminated

FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.

FDA Recall Z-0834-2007 · Posted 2007-05-31

Recalling FirmKensey Nash Corp
Recall StatusTerminated
Product CodeFRO
Date Initiated2007-03-28
Date Terminated2007-08-30
Product Quantity109 units

Reason for Recall

Insufficient wire sealing

Firm Action

On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.

Root Cause

Other

Distribution Pattern

Worldwide, including USA and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061772TRIACTIV FX EMBOLIC PROTECTION SYSTEMKensey Nash Corp. · 2006-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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