B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
FDA device recall Z-2489-2019 · posted 2019-09-23 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
- Action taken
- Urgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2580
- Distribution
- Distribution to US state of TX, and Canada.
- Date initiated
- 2019-05-01
- Date posted
- 2019-09-23
- Date terminated
- 2020-07-13
- Location
- Allentown, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS (K142036) | B.Braun Medical, Inc. | 2014-08-25 |