Regard Retinal Pack surgical kits recalled for defective 3M drapes
ROi CPS LLC is recalling Regard Retinal Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained recalled 3M surgical drapes.
What this means for you
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 surgical equipment used in eye surgery procedures. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Regard Retinal Pack surgical convenience kits, Item Number 800730003, have been recalled by ROi CPS LLC. Approximately 32 kits were distributed in Louisiana, Missouri, North Carolina, and Florida, with lot numbers 92674 and 93459 (both expiring September 30, 2023).
The kits are being recalled because they contained 3M surgical drapes that were subsequently recalled. Affected healthcare providers and patients should stop using these kits immediately and contact ROi CPS LLC regarding returns or replacement options.
The recalled product
- Product
- regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 32
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 (4)
- UDI/DI 10194717101611
- Lot Numbers: 92674
- exp 9/30/2023
- 93459
Distribution
Part of a larger recall action
This product is one of 40 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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