Fresenius CRIT-LINE Blood Chamber Recalled for Connection Leaks
Fresenius Medical Care is recalling CRIT-LINE Blood Chambers because the connection may leak during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a leak in a blood chamber, which poses a significant risk of injury or harm to patients.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the CRIT-LINE Blood Chamber, an accessory to the Crit line III that monitors blood parameters in real time. The recall is due to a defect where the blood chamber connection leaks during use.
The recall covers 22,640,288 units of the product, model CL10021021, across all lot numbers. The affected products were distributed worldwide, including nationwide distribution in the United States and Puerto Rico, as well as in Ireland, Spain, Slovenia, Great Britain, the Netherlands, Norway, Mexico, Egypt, and the Czech Republic.
Consumers and healthcare providers should stop using the affected blood chambers and contact the manufacturer for instructions on replacement or refund.
The recalled product
- Product
- CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 22,640,288
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 (1)
- All lot numbers
Distribution
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