FDA-Device2016-03-16Class II

Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr. Rx

Arrow International Inc

Hazard

Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.

Sold states

Nationwide Distribution including AL AR AZ CA CO CT DE FL GA IA ID IL IN KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC TN TX UT VA VT WA WI WV

Affected count

56,521 units

Manufactured in

2400 Bernville Rd, N/A, Reading, PA, United States

Products

Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr. Rx only. The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2016

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