Regard Kit Decanters Recalled for Defective Sterile Packaging
ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.
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 compromised sterile packaging on a medical device. The packaging defect represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to defects in the sterile packaging. The decanters may have pin holes and tears in their sterile packaging that cannot be identified visually.
Lot numbers 99206 and 100633 (expiration date September 15, 2024) are affected. The kits were distributed nationwide in the state of Missouri.
The recalled product
- Product
- Regard Kit containing the Microtek decanter
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device
- Affected units
- 78
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 (2)
- Item Number: 830099009
- UDI: 10194717116677
Distribution
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