ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box.
FDA Recall Z-0835-2007 · Posted 2007-05-31
Recalling FirmKensey Nash Corp
Recall StatusTerminated
Product CodeFRO
Date Initiated2007-03-28
Date Terminated2007-08-30
Product Quantity11 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.