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Terminated

ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063

FDA Recall Z-1091-04 · Posted 2004-07-20

Recalling FirmFox Hollow Technologies
Recall StatusTerminated
Date Initiated2004-06-17
Date Terminated2004-10-25
Product Quantity127 units

Reason for Recall

Devices for which sterility may be compromised.

Firm Action

On 6/18/04, all consignees were notified via phone call, written letter and on-site visit by the firm's sales reps, informing them of the affected product and providing instructions on the recall.

Root Cause

Other

Distribution Pattern

The product received nationwide distribution to 59 medical facilities/doctor's offices and 4 units distributed to firm's field agents.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024243REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406Fox Hollow Technologies · 2003-06-20

Official Source

View FDA Recall →

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

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