Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 25, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde ri…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
B Braun Medical Inc recalled STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and… - a moderate-severity action.
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and… was recalled by B Braun Medical Inc in September 25, 2024. Reason: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the…. Check the official notice for the remedy. Verify recall #Z-3175-2024 with the FDA Devices before acting.
The recall
B Braun Medical Inc issued this moderate-severity FDA Devices recall-Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the….
- Moderate
- severity level
- 5.0M units
- affected scope
- Class II
- classification
- September 25, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3175-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3175-2024) was formally reported on September 25, 2024, with the manufacturer initiating the action on August 15, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. B Braun Medical Inc is listed as the recalling firm, operating out of Bethlehem, PA. Federal records list the affected scope as 4984920 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: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient conne… Distribution data in the federal record shows the product reached: US Nationwide distribution.. 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
4984920 units
Related Recalls
6
3 from same agency
Product description
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
Reason for recall
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-3175-2024 |
| Date reported | September 25, 2024 |
| Date initiated | August 15, 2024 |
| Recalling firm | B Braun Medical Inc |
| Firm location | Bethlehem, PA |
| Affected scope | 4984920 units |
| Distribution | US Nationwide distribution. |
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-3175-2024) 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? ▼
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA. Recalled by B Braun Medical Inc. Units affected: 4984920 units.
Why was this product recalled? ▼
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3175-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3175-2024) 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 September 25, 2024. 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.