Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Reported: July 6, 2022 Initiated: May 4, 2022 #Z-1303-2022
Product Description
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Reason for Recall
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 19 cases
- Distribution
- US Nationwide distribution in the state of Pennsylvania.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 19 cases.
Why was this product recalled? ▼
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1303-2022.
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