CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report
Filtered Triple-Leg Extension Set - Intravascular administration set recalled
B. Braun Medical is recalling Filtered Triple-Leg Extension Set - Intravascular administration set, distributed nationwide in the US. The recall was initiated on 15 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1509-2021
- FDA event ID
- 87585
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2021
- FDA classified
- 29 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 15 Mar 2021 | Recall initiated by company | |
| 29 Apr 2021 | Classified by FDA | +45 days |
| 5 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
Product as listed by the FDA
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
Where it was distributed
US Nationwide distribution in the states of NC, CA.
Questions about this recall
Why was it recalled?
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
Which lots are affected?
Lot #: 00SL713784, 0061741483, 0061755034, 0061755296
Where was it sold?
US Nationwide distribution in the states of NC, CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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