Recall Z-2489-2019— B. Braun Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by B. Braun Medical, Inc., initiated 2019-05-01, terminated 2020-07-13. It names one FDA 510(k) clearance: K142036. Product: B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032. Reason: Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site)..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-05-01
- Terminated
- 2020-07-13
- Firm location
- Allentown, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.