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Terminated

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

FDA Recall Z-2274-2010 · Posted 2010-08-25

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeKGZ
Date Initiated2010-06-07
Date Terminated2012-09-29
Product Quantity3000 kits

Reason for Recall

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.

Firm Action

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

Root Cause

Process change control

Distribution Pattern

All affected product was distributed to one foreign consignee: Arrow Japan Ltd.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K781846ADAPTER, CATHETER SHEATHArrow Intl., Inc. · 1978-12-12

Official Source

View FDA Recall →

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

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