Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 29, 2016
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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Medical Care Renal Therapies Group, LLC recalled Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor… - a moderate-severity action.
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor… was recalled by Fresenius Medical Care Renal Therapies Group, LLC in June 29, 2016. Reason: Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result …. Check the official notice for the remedy. Verify recall #Z-2044-2016 with the FDA Devices before acting.
The recall
Fresenius Medical Care Renal Therapies Group, LLC issued this moderate-severity FDA Devices recall-Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result ….
- Moderate
- severity level
- 875 units
- affected scope
- Class II
- classification
- June 29, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2044-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2044-2016) was formally reported on June 29, 2016, with the manufacturer initiating the action on May 24, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Fresenius Medical Care Renal Therapies Group, LLC is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 875 units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Distributed US (nationwide). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
875 units
Related Recalls
6
3 from same agency
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
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2044-2016 |
| Date reported | June 29, 2016 |
| Date initiated | May 24, 2016 |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Firm location | Waltham, MA |
| Affected scope | 875 units |
| Distribution | Distributed US (nationwide) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2044-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 875 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2016. Severity: Moderate. Recall number: Z-2044-2016.
Where was the recalled product distributed? ▼
Distribution: Distributed US (nationwide).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2044-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 29, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.