—#176672

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.

FDA product code: NIE — Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K133456
Affected lot / code info: REDR0440

Why it was recalled

A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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

Timeline

Recall initiated: 2019-09-16
Terminated: 2020-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.