FDA-Device2019-12-25Class II
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Arrow International Inc
Hazard
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
Sold states
U.S. Nationwide, Canada
Affected count
1 unit
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2020Don't want to check this manually?
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