FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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.
- Recall number
- Z-0285-2020
- Recalling firm
- Becton Dickinson & Company
- 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.
- Status
- Terminated
- Initiated
- 2019-09-16
- Posted
- not on file
- Terminated
- 2020-06-29
- Reason
- A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
- 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
- 75 units
- Distribution
- Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.
- Lot, serial or model codes
- REDR0440
- 510(k) numbers
- K133456
- PMA numbers
- not on file
- Product code
- NIE
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06