Z-0819-2022 Class II Terminated
FDA device recall Z-0819-2022 was initiated by B Braun Medical Inc on Feb 7, 2022 and is designated Class II. Reason for recall: Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in… The recall status is terminated (terminated Dec 28, 2023). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 30, 2022
- Initiation Date
- Feb 7, 2022
- Termination Date
- Dec 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Reason for Recall
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
Distribution Pattern
US Distribution to states of: MA, VT
Code Information
Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0819-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026