Z-0285-2020Class II

13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis...

Name: Z-0285-2020 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis...
Creator: Becton Dickinson & Company
Published: 2019-09-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-09-16 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third... on 2019-09-16. FDA classified it as Class II and gives the reason as "A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0285-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Posted: 2019-11-05
Terminated: 2020-06-29
Recalling firm: Becton Dickinson & Co
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.
Product code: NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Reason for recall: A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On September 16, 2019, the firm distributed Urgent Medical Device Recall notices to affected customers. Customers were asked to take the following actions: 1. Immediately examine your inventory for the product code and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Please share this recall notification with all users of the product to ensure they are also aware of the recall. 3. Complete the Customer Response Form (even if you do not have affected lots in your inventory) and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement or credit. 4. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. The firm will provide product replacement or credit for all discarded inventory. If you have any questions or require assistance with the return of the recalled product please contact our recall coordinator at 1-800-290-1689 between 8 AM and 5 PM MST Monday through Friday.
Quantity in commerce: 75 units
Distribution: Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.
Product codes and lots: REDR0440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0285-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0285-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-05

Product code NIE

K133456Class IIPower-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. / cleared 2014-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)