Olympus Guide Sheath Kits recalled for potential radiopaque tip detachment
Olympus Single Use Guide Sheath Kits (models K-201 through K-204) are recalled because the radiopaque tip of the guide sheath may detach and fall into the patient during respiratory procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I medical device recall involves a known potential hazard. The radiopaque tip may disassociate and fall into the patient during a respiratory procedure. The FDA's Class I classification mandates a minimum severity level of 4.
Plain-English summary
Olympus Corporation of the Americas is recalling four models of Single Use Guide Sheath Kits (K-201, K-202, K-203, K-204) used to collect tissue and cell samples from the respiratory system. Approximately 454 units have been distributed nationwide.
The kits are being recalled because the radiopaque tip of the guide sheath component may disassociate and fall into the patient. This defect affects all lots of all four recalled models.
The FDA has classified this as a Class I recall. The recall notice and additional information about this product are available through the FDA's recall database.
The recalled product
- Product
- Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 454
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 (9)
- 1. Model Number: K-201
- UDI-DI: 04953170245466
- All Lots. 2. Model Number: K-202
- UDI-DI: 04953170245480
- All Lots 3. Model Number: K-203
- UDI-DI: 04953170245503
- All Lots 4. Model Number: K-204
- UDI-DI: 04953170245527
- All Lots
Distribution
Distributed nationwide across the United States.
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