Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 10, 2019
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Baxter Healthcare Corporation recalled REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzer… - a moderate-severity action.
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzer… was recalled by Baxter Healthcare Corporation in July 10, 2019. Reason: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.. Check the official notice for the remedy. Verify recall #Z-1908-2019 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this moderate-severity FDA Devices recall-There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment..
- Moderate
- severity level
- 1.2M units
- affected scope
- Class II
- classification
- July 10, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1908-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1908-2019) was formally reported on July 10, 2019, with the manufacturer initiating the action on May 31, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 1249272 units, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. Distribution data in the federal record shows the product reached: US Nationwide Distribution and Internationally to: Canada and Bermuda.. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
1249272 units
Related Recalls
6
6 from same agency
Product description
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason for recall
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1908-2019 |
| Date reported | July 10, 2019 |
| Date initiated | May 31, 2019 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 1249272 units |
| Distribution | US Nationwide Distribution and Internationally to: Canada and Bermuda. |
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-1908-2019) 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? ▼
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.. Recalled by Baxter Healthcare Corporation. Units affected: 1249272 units.
Why was this product recalled? ▼
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1908-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution and Internationally to: Canada and Bermuda..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1908-2019) 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.
Nearby Recalls in This Category
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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 July 10, 2019. 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 August 2026.