FDAClass IIApril 17, 2024

Hemostasis Probe recall

Hemostasis Probe, Model: CD-B622LA

Why was Hemostasis Probe recalled?

The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212

Product
Hemostasis Probe, Model: CD-B622LA
Recalling firm
Olympus Corporation of the Americas
Quantity
36 units (all OUS)
Distribution
International distribution only.
Recall date
April 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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