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Terminated

Arrow Percutaneous Sheath Introducers

FDA Recall Z-1493-2009 · Posted 2009-06-24

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeKGZ
Date Initiated2009-02-11
Date Terminated2010-07-22
Product Quantity900,000 total, all products

Reason for Recall

Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

Firm Action

Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.

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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