—#124291

Product

Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: N/A

Why it was recalled

Bicarbonate Jug Adapter distributed prior to 510(k) approval

Root cause (FDA determination)

No Marketing Application

Action the firm took

Fresenius notified customers by telephone and Formal notification on 12/17/13 via the Urgent Bicarbonate Jug Adapter Recall letter sent certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they are instructed to discontinue use and place all Bicarbonate Jug Adapters in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-12-17
Posted by FDA: 2014-02-03
Terminated: 2021-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.