Eye Surgery Convenience Kits Recalled for Containing Recalled 3M Drapes
ROi CPS LLC recalled 76 regard Vitrectomy Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained 3M surgical drapes that were subsequently recalled.
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: This is an FDA Class II recall of surgical devices, which are risk-of-harm products by nature. No illnesses or injuries have been reported in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score as 3 (High).
Plain-English summary
ROi CPS LLC is recalling 76 regard VITRECTOMY PACK surgical kits (Model EY00266H, Item Number 800028008). These surgical convenience kits, classified as Class II by the FDA, were distributed in Louisiana, Missouri, North Carolina, and Florida. The kits are being recalled because they contain 3M surgical drapes which were subsequently recalled.
The affected lot is Lot Number 92222 with an expiration date of April 2024. The Universal Device Identifier (UDI) is 10194717107897.
The recalled product
- Product
- regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 76
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 (3)
- UDI/DI 10194717107897
- Lot Numbers: 92222
- exp 4/21/2024
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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