Hip Arthroplasty Surgical Convenience Kits Recalled Due to Defective 3M Drapes
ROi CPS LLC is recalling regard TOTAL HIP ARTHROPLASTY surgical convenience kits containing recalled 3M surgical drapes distributed to facilities 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: This is an FDA Class II recall of a medical device (surgical drapes) used in orthopedic surgery. Although no illnesses or injuries are reported and the specific hazard is not detailed, surgical equipment is a risk-of-harm product; a recall of surgical drapes without reported injury meets the High severity criteria.
Plain-English summary
ROi CPS LLC is recalling regard TOTAL HIP ARTHROPLASTY A&B surgical convenience kits because the kits contain 3M surgical drapes that were subsequently recalled. The kits, Item Number 880028023 with UDI/DI 10194717113911, were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
A total of 125 kits were affected. Lot numbers 91560 (expiration 12/7/2023) and 92467 (expiration 2/14/2024) are included in the recall.
The specific reason for the 3M drape recall is not described in this notice.
The recalled product
- Product
- regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; 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 (5)
- UDI/DI 10194717113911
- Lot Numbers: 91560
- exp 12/7/2023
- 92467
- exp 2/14/2024
Distribution
Distributed in 4 states:
- FL
- LA
- MO
- NC
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