FDAClass IIMarch 30, 2022

PERFUSOR SPACE - US VERSION. Intended Use: syringe recall: Labeling Error

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

Why was PERFUSOR SPACE - US VERSION. Intended Use: syringe recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number…
Recalling firm
B Braun Medical Inc
Quantity
6 units
Distribution
US Distribution to states of: MA, VT
Recall date
March 30, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
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