Shoulder arthroscopy surgical convenience kits recalled due to defective 3M drapes
ROi CPS LLC is recalling 90 regard shoulder arthroscopy surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
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 of a surgical device containing a recalled component. No reported illnesses or injuries, but surgical drapes are critical components in procedures; the inclusion of a recalled drape poses risk of harm. Under the severity rubric, this meets the criteria for High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
ROi CPS LLC is recalling 90 regard SHOULDER ARTHROSCOPY surgical convenience kits (model OR01103A, item number 880471001) because they contain 3M surgical drapes that were subject to a subsequent recall.
The affected kits (lot number 92206, with expiration date January 2026) were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. The kits can be identified by UDI/DI 10174717114185.
Healthcare facilities and surgical departments should discontinue use of these kits immediately. Facilities in the affected states should verify that they did not receive kits from the affected lot number and contact ROi CPS LLC for replacement or return instructions.
The recalled product
- Product
- regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- surgical-drape-defect
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 10174717114185
- Lot Numbers: 92206
- exp 1/26/2024
Distribution
Distributed in 4 states:
- FL
- LA
- MO
- NC
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