Regard Kit containing the Microtek decanter
FDA device recall Z-2685-2024 · posted 2024-08-16 · Open, Classified
Recall details
- Recalling firm
- ROi CPS LLC
- Reason for recall
- Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
- Action taken
- The distributor was notified of the recall via letter emailed on 06/17/2024. The distributor was instructed to review their inventory to determine if the item listed in the letter is in the inventory; complete and return a response form, notify any customers to whom the product was distributed, end users should immediately quarantine any affected kits at their facility and discontinue use, and report any adverse health consequences experienced with the product to FDA.
- Root cause
- Pending
- Status
- Open, Classified
- Product code
- KPE
- Quantity affected
- 78 Kits
- Distribution
- US Nationwide distribution in the state of MO.
- Date initiated
- 2024-06-17
- Date posted
- 2024-08-16
- Location
- Republic, MO
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