ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues
Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Sterile medical devices with potential barrier compromise meet the criterion of risk-of-harm products where injury has not yet been reported. No illnesses have been reported, but sterility compromise on medical procedure devices presents a risk of harm.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE brand medical procedure kits for ear cleaning due to reports of packaging issues that may result in a breach of the sterile barrier.
Two models are affected: Model 96-2273 (Buck Ear Cur) and Model 96-2283 (Billeau Ear Loop). Both are marked with Lot Code SK-129 and contain 25 sterile units per kit. The UDI codes are 50649111448735 (Model 96-2273) and 50649111448780 (Model 96-2283).
The affected kits have been distributed nationwide.
The recalled product
- Product
- ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
- Manufacturer
- Sklar Instruments
- Affected units
- 25
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)
- 1) 96-2273
- UDI/DI 50649111448735
- Lot Codes: SK-129
- 2) 96-2283
- UDI/DI 50649111448780
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Sklar Instruments 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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