Regard, Item Number 830067009, custom cardiovascular procedure kit
Reported: April 14, 2021 Initiated: March 4, 2021 #Z-1376-2021
Product Description
Regard, Item Number 830067009, custom cardiovascular procedure kit
Reason for Recall
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
Details
- Recalling Firm
- ROi CPS LLC
- Units Affected
- 16 kits
- Distribution
- US Nationwide distribution in the state of Missouri.
- Location
- Republic, MO
Frequently Asked Questions
What product was recalled? ▼
Regard, Item Number 830067009, custom cardiovascular procedure kit. Recalled by ROi CPS LLC. Units affected: 16 kits.
Why was this product recalled? ▼
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1376-2021.
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