FDA-Device2015-03-18Class II
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Arrow International Inc
Hazard
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Sold states
Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
Affected count
166 units
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1259-2015Don't want to check this manually?
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