Medical device manufacturer recalls hemodialysis machines for potential PCBA leaching
Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class I FDA medical device recall, which establishes a minimum severity floor of 4. No deaths, hospitalizations, or illnesses have been reported in the source. The hazard is characterized as potential leaching, not confirmed harm, keeping it at Severe rather than Critical.
Plain-English summary
Fresenius Medical Care Holdings, Inc. has issued a Class I recall of 733 units of the 2008T GEN 2 Bibag hemodialysis machine (Model No. 190895, without CDX). The device is used in hemodialysis treatment to filter waste and excess water from the blood of patients with kidney failure.
The recall was issued because of potential leaching of printed circuit board assembly (PCBA) materials from the tubing. This leaching could contaminate the dialysate fluid used during treatment, posing a potential health risk to patients depending on the extent and composition of any leachate.
All 733 recalled units were distributed nationwide within the United States. Affected units can be identified by the specific serial numbers listed in the recall notice, which range from serial numbers beginning with 1T0S, 2T0S, 8T0S, 9T0S, and 0T0S.
Patients and healthcare facilities currently using affected units should contact Fresenius Medical Care for guidance. The FDA has designated this as a Class I recall, indicating a potential serious health hazard. Users should not discontinue dialysis treatment without consulting their healthcare provider.
The recalled product
- Product
- 2008T GEN 2 Bibag without CDX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- pcba-leaching
- chemical-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No: 190895
- UDI-DI: 00840861100927
- Serial No. 1T0S261032
- 1T0S261004
- 1T0S261029
- 1T0S260995
- 1T0S260937
- 1T0S260739
- 1T0S260687
- 1T0S260573
- 2T0S263945
- 2T0S263947
- 2T0S263959
- 2T0S263924
- 2T0S263962
- 2T0S263956
- 2T0S263951
- 2T0S263950
- 2T0S263707
- 2T0S263692
Distribution
Distributed nationwide across the United States.
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