Recall Z-0285-2020— Becton Dickinson & Company

Name: FDA recall Z-0285-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-09-16, terminated 2020-06-29. It names one FDA 510(k) clearance: K133456. 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: A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Terminated: 2020-06-29
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133456 — POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERC.R. Bard, Inc.·cleared 2014-09-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.