Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.
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: FDA Class II medical device with reported packaging defects that may compromise sterile barrier integrity. No illnesses or injuries have been reported; the hazard is theoretical but represents a significant risk for products used in invasive tracheal procedures.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE TROUSSEAU DILATOR kits (Model 941-0191) that were distributed nationwide. The product is designed for tracheal procedures and is marketed in a 25-unit pack (CS/25). The recall was triggered by reports of various packaging issues.
The packaging defects may result in a breach of the sterile barrier, which is critical for medical devices intended for sterile procedures. A compromised sterile barrier could expose the instruments to contamination during storage or handling.
Healthcare facilities that have received these kits should immediately cease use and verify whether they have affected products by checking for Model Number 941-0191 and Lot Code 9249410191. Affected providers should contact Sklar Instruments for information regarding returns or replacements.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
- Manufacturer
- Sklar Instruments
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 (2)
- 941-0191
- UDI/DI 50649111232730. Lot codes: 9249410191
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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