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.
This recall has been terminated (originally issued February 3, 2014).
- Recall Initiated
- December 17, 2013
- Posted
- February 3, 2014
- Terminated
- May 18, 2021
- Recall Number
- Z-0920-2014
- Quantity
- 703 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Bicarbonate Jug Adapter distributed prior to 510(k) approval
Distribution
Nationwide Distribution.
Root Cause
No Marketing Application
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.