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Recall Observatory FDA recall evidence

Device product

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U

Z-0819-2022

February 07, 2022

Class II

Product summary

Firm
B Braun Medical Inc
Event
Event 89660
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0819-2022

Official wording

Reason: 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.

Code information: Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745

Distribution pattern: US Distribution to states of: MA, VT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.