Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket t

FDA device recall Z-0920-2014 · posted 2014-02-03 · Terminated

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

Reason for recall

Bicarbonate Jug Adapter distributed prior to 510(k) approval

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

KDI

Quantity affected

703 units

Distribution

Nationwide Distribution.

Date initiated

2013-12-17

Date posted

2014-02-03

Date terminated

2021-05-18

Location

Waltham, MA