Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
FDA Recall Z-0784-2010 · Posted 2010-03-05
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2009-11-24
Date Terminated2012-01-18
Product Quantity65 kits
Reason for Recall
Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
Firm Action
The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
Root Cause
Nonconforming Material/Component
Distribution Pattern
The products were shipped to distributors in GA, MD, and VA.
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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