Surgical convenience kits recalled due to defective surgical drapes
Regard MAJOR EAR surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida are being recalled because the kits contained 3M surgical drapes that were subsequently recalled.
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 used in medical procedures, which is inherently a risk-of-harm product. Although no illnesses or injuries have been reported and the specific defect is not detailed in the recall notice, the Class II classification indicates potential for serious adverse health consequences. Per the rubric, recalls of risk-of-harm products without yet-reported injuries are classified as High.
Plain-English summary
The FDA has issued a recall for Regard MAJOR EAR surgical convenience kits (Item Number 800070010) manufactured by ROi CPS LLC. This is a Class II recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
The reason for the recall is that the surgical convenience kits contained 3M surgical drapes which were subsequently recalled.
Affected lot numbers are 92037 (expiration 1/31/2023) and 91205 (expiration 6/30/2023), with a total of 200 kits recalled.
The recalled product
- Product
- regard MAJOR EAR, ET00326J, Item Number 800070010; ear 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 10194717079958
- Lot Numbers: 92037
- exp 1/31/2023
- 91205
- exp 6/30/2023
Distribution
Distributed in 4 states:
- FL
- LA
- MO
- NC
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