—#92259

Product

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

FDA product code: KGZ — Accessories, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K781846
Affected lot / code info: Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

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

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

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

Timeline

Recall initiated: 2010-06-07
Posted by FDA: 2010-08-25
Terminated: 2012-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92259. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.