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
- Affected units
- 125
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
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.
See all 40 products in this recall →Related recalls
Same manufacturer · ROi CPS LLC
See all →- HighNewborn Resuscitator Kit Recalled for Inline Spring Defect
FDA (Devices) · 2025-02-12
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighRegard Kit Decanters Recalled for Defective Sterile Packaging
FDA (Devices) · 2024-08-28
- CriticalSurgical Convenience Kit Recalled Due to Defective Component
FDA (Devices) · 2024-01-24
- SevereRegard Dressing Change Kit Recalled Due to Defective Irrigation Solution
FDA (Devices) · 2024-01-10
Same hazard · surgical drape defect
See all →- HighDeRoyal Shoulder Arthroscopy Procedure Packs Recalled Due to Defective Surgical Drapes
FDA (Devices) · 2022-12-21
- HighRegard Retinal Pack surgical kits recalled for defective 3M drapes
FDA (Devices) · 2022-11-30
- ModerateEye Surgery Convenience Kits Recalled for Defective Surgical Drapes
FDA (Devices) · 2022-11-30
- HighSurgical Convenience Kits Recalled Due to Recalled Surgical Drapes
FDA (Devices) · 2022-11-30
- ModerateFDA Class II Recall of Surgical Convenience Kits with Recalled 3M Surgical Drapes
FDA (Devices) · 2022-11-30