Arrow International Inc recalls (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Ba…

Recall date

December 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1329-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Why it was recalled

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-KH; (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-LC; (4) PSI Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-PHP; (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09907-LGH1; (6) Arrow PSI Kit, Part Number: CDC-09803-1A; (7) Arrow PSI Kit, Part Number: CDC-09903-1A