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.
Reported: February 12, 2014 Initiated: December 17, 2013 #Z-0920-2014
Product Description
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.
Reason for Recall
Bicarbonate Jug Adapter distributed prior to 510(k) approval
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 703 units
- Distribution
- Nationwide Distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 703 units.
Why was this product recalled? ▼
Bicarbonate Jug Adapter distributed prior to 510(k) approval
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2014. Severity: Moderate. Recall number: Z-0920-2014.
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