Surgical Convenience Kits Recalled Due to Recalled Surgical Drapes
Regard ACDF surgical convenience kits containing 3M surgical drapes that were subsequently recalled are being recalled by ROi CPS LLC. Approximately 30 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: This FDA Class II recall involves surgical equipment with no reported illnesses or injuries. The recall of a component within surgical kits represents a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.
Plain-English summary
Regard ACDF surgical convenience kits, Item Number 800246009 (UDI 10194717110811), manufactured by ROi CPS LLC have been recalled. These surgical convenience kits for neurosurgical procedures contain 3M surgical drapes that were subsequently recalled.
The affected kits are identified by Lot Number 92354 with an expiration date of January 31, 2023. Approximately 30 kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
Healthcare facilities that received these kits should discontinue use and isolate the recalled kits from inventory. For more information or return instructions, contact ROi CPS LLC.
The recalled product
- Product
- regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 30
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 10194717110811
- Lot Numbers: 92354
- exp 1/31/2023
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
- HighHip Arthroplasty Surgical Convenience Kits Recalled Due to Defective 3M Drapes
FDA (Devices) · 2022-11-30
- ModerateEye Surgery Convenience Kits Recalled for Defective 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