FDA Recall
Terminated
Respirator Crash Cart Kit
Recall: Z-2466-2020
·
Initiated May 19, 2020
Recall
- Recall Number
- Z-2466-2020
- Event Number
- 85736
- Firm
- ROi CPS LLC
- FEI Number
- 3014527682
- Product Code
- OEV
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- May 19, 2020
- Terminated
- September 1, 2020
- Address
- 3000 E Sawyer Rd, Republic, MO, 65738-2758
Description
Respirator Crash Cart Kit
Reason
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Action
On May 19, 2020 Roi CPS LLC notified its customers to review their inventory to determine if the custom procedure kit item and lot identified were on their inventory. If identified, please quarantine and notify Roi of the quantity on hand completing the reply form provided to them via email and to forward this notification to all potential user of the recall.
Distribution
Domestic distribution only to: MO and LA.
Quantity
200 kits