Regard GS0098C Bronchoscopy Kit Recalled for Included Recalled Cleaning Products
ROi CPS LLC has recalled the Regard GS0098C bronchoscopy kit because it contained Medline Endoscopy Bedside Cleaning products that were previously recalled.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, based on the kit containing Medline cleaning products that were previously recalled. The specific hazard is not detailed in the recall notice.
Plain-English summary
ROi CPS LLC is recalling the Regard GS0098C Reusable Respiratory Bronchoscopy convenience kit (Item Number 830086003) because it contained Medline Endoscopy Bedside Cleaning products that were previously recalled. The affected kit lot is numbered 90135 with an expiration date of May 31, 2023, and was distributed in Florida.
The exact nature of the defect or hazard in the included Medline cleaning products is not specified in this FDA recall notice. Approximately 24 kits were affected by this recall.
The recalled product
- Product
- regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 24
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)
- UDI (01)10194717102335(17)230531(10)90135
- Lot Number 90135
- Exp. 2023-05-31
Distribution
Distributed in 1 state:
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