Medical device recalls Moderate risk

Becton Dickinson & Company recalls 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacur…

Recall date
September 16, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0285-2020
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.

Why it was recalled

A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

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

What was recalled

13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.

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