Surgical kits recalled: Regard VITRECTOMY PK contained 3M recalled components
Regard VITRECTOMY PK surgical convenience kits are being recalled because they contain 3M surgical drapes that were separately recalled. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
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: FDA Class II medical device recall of surgical kits with no reported injuries or deaths. This is a risk-of-harm product where injury has not been reported, justifying a High severity rating.
Plain-English summary
ROi CPS LLC has recalled 8 regard VITRECTOMY PK surgical convenience kits (Item Number 800733003) because the kits contained 3M surgical drapes that were separately recalled. The affected lot number is 92327, with an expiration date of April 26, 2024.
The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Those who received these kits should immediately stop using them and contact the manufacturer or FDA for guidance on proper disposal and replacement options.
The recalled product
- Product
- regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 8
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 10194717109297
- Lot Numbers: 92327
- exp 4/26/2024
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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