FDA recall Z-0285-2020

Product

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.

Distribution

Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.

Key facts

Status

Terminated

Initiation date

2019-09-16

Report date

2019-11-13

Termination date

2020-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0285-2020