Data Foundry

Medical device recalls 2019

13 Fr — Class II medical device recall Z-0285-2020

Terminated recall by Becton Dickinson & Company, reported 2019-11-13, distributed in AR, FL, IL, NJ, TX, WI. A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

Recall numberZ-0285-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Company, Franklin Lakes, NJ, United States
Recall initiated2019-09-16
Classified2019-11-05
Reported by FDA2019-11-13
Terminated2020-06-29
DistributedAR, FL, IL, NJ, TX, WI
Quantity75 units
UPC / GTIN / UDI-DI00801741066023
Model numbers5653150

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0285-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.