Recall record at a glance
| Official record | Z-2044-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Report date | Jun 29, 2016 |
| Recall initiation date | May 24, 2016 |
| Quantity | 875 units |
| Location | Waltham, MA, United States |
Official product description
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX
Why the product was recalled
Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
Distribution information
Distributed US (nationwide)
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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