Olympus Hemostasis Probe Mispackaged with Wrong Connector Type
Olympus Corporation is recalling 36 units of Hemostasis Probe Model CD-B622LA that were mispackaged with the wrong connector type and labeled incorrectly. Healthcare facilities using the wrong device could experience use errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a product-labeling mismatch that could result in improper use by healthcare professionals. While no injuries have been reported, the risk of use error with medical equipment warrants a High severity classification per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Olympus Corporation of the Americas is recalling 36 units of the BICOAG Hemostasis Probe, Model CD-B622LA (Lot KR214212) due to mispackaging during manufacturing.
The affected units contain a coaxial plug connector but were labeled as having a fixed pin connector. This mismatch could cause healthcare professionals to improperly connect or use the device, potentially resulting in use errors.
All affected units were distributed internationally only. No injuries or illnesses have been reported. The unique device identifier (UDI) is 00821925039452.
If you have received this product, verify the connector type against your order and contact Olympus Corporation of the Americas if there are any discrepancies.
The recalled product
- Product
- Hemostasis Probe, Model: CD-B622LA
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: CD-B622LA
- UDI/DI: 00821925039452
- Lot Number: KR214212
Distribution
Distribution scope not specified by the agency.
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