Recalls / —
—#173239
Product
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K142036
- Affected lot / code info
- Lot Number 0061641410
Why it was recalled
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Root cause (FDA determination)
Other
Action the firm took
Urgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers.
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Address
- 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512
Distribution
- Distribution pattern
- Distribution to US state of TX, and Canada.
Timeline
- Recall initiated
- 2019-05-01
- Posted by FDA
- 2019-09-23
- Terminated
- 2020-07-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.