FDA-Device2015-02-04Class III

Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

Arrow International Inc
Hazard

Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

Sold states
US (nationwide) and PR.
Affected count
4484
Manufactured in
2400 Bernville Road, N/A, Reading, PA, United States
Products
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2015

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