FDA Device

Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801

Hazard

Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.

What You Should Do

Remedy

June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.

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Products

Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
Brand
Arrow International Inc
UPC
Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262

Units Affected

3000 kits

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