Z-2489-2019 Class I Terminated
FDA device recall Z-2489-2019 was initiated by B. Braun Medical, Inc. on May 1, 2019 and is designated Class I. 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). The recall status is terminated (terminated July 13, 2020). Affected quantity: 2580.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2019
- Initiation Date
- May 1, 2019
- Termination Date
- July 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2580
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).
Distribution Pattern
Distribution to US state of TX, and Canada.
Code Information
Lot Number 0061641410