Z-0819-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2022
- Initiation Date
- February 7, 2022
- Termination Date
- December 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