PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 13, 2019 Initiated: September 16, 2019 #Z-0285-2020

Product Description

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.

Reason for Recall

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

Details

Units Affected
75 units
Distribution
Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product 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.. Recalled by Becton Dickinson & Company. Units affected: 75 units.
Why was this product recalled?
A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0285-2020.