Device product

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

Z-2489-2019

May 01, 2019

Class I

Product summary

Firm: B. Braun Medical, Inc.
Event: Event 82966
Status: Terminated
Classification: Class I
Quantity: 2580
Official record key: device-enforcement:Z-2489-2019

Official wording

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).

Code information: Lot Number 0061641410

Distribution pattern: Distribution to US state of TX, and Canada.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).