Surgical convenience kits recalled for defective 3M drape components
ROi CPS LLC recalls 213 surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The affected 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 is a risk-of-harm medical device (surgical convenience kit) classified by FDA as Class II. No illnesses or injuries have been reported. The product classification and its intended use in healthcare settings justify a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ROi CPS LLC is recalling surgical convenience kits (¿regard SHOULDER PK, GS00125U, Item Number 880120021) used for orthopedic surgery. These kits were distributed containing 3M surgical drapes which were subsequently recalled by the manufacturer.
The recall affects 213 kits that were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. The affected lots are numbered 91005 (expiration 2/27/2023) and 91543 (expiration 2/16/2024), with UDI/DI 10194717103301.
Healthcare facilities and surgical centers in the affected areas should verify their inventory for these recalled kits. Facilities with affected units should remove them from service and contact the manufacturer regarding replacement or disposal options.
The recalled product
- Product
- ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 213
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 10194717103301
- Lot Numbers: 91005
- exp 2/27/2023
- 91543
- exp 2/16/2024
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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