Recalls / —
—#186367
Product
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.
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K153293, K942988
- Affected lot / code info
- Lot #: 00SL713784, 0061741483, 0061755034, 0061755296
Why it was recalled
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
On 03/12/2021, B. Braun issued an Urgent Medical Device Recall notice via letter notifying customers of the potential for the extension set to become occluded or unable to prime.
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Address
- 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512
Distribution
- Distribution pattern
- US Nationwide distribution in the states of NC, CA.
Timeline
- Recall initiated
- 2021-03-15
- Terminated
- 2022-06-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #186367. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.