ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
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 Class II medical device recall involves a potential sterile barrier breach on surgical instruments. Although no illnesses or injuries have been reported, the sterile compromise risk on devices intended for surgical use represents a high-risk concern.
Plain-English summary
Sklar Instruments is recalling 2,500 ECONO STERILE medical procedure kits sold nationwide. The recalled products are orthopedic probes in two models: 94-5923 (50-unit cartons) and 96-2361 (25-unit cartons).
The recall was issued due to reports of packaging issues that may result in a breach of the sterile barrier in these medical devices. The affected lot codes are SK-115 and SK-116 for Model 94-5923, and SK-115 for Model 96-2361.
Customers who have received these products should discontinue use and contact Sklar Instruments regarding replacement or return. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- packaging-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 (7)
- 1) 94-5923
- UDI/DI 50649111181663
- Lot codes: SK-115
- SK-116
- 2) 96-2361
- UDI/DI 50649111392601
- Lot codes: SK-115.
Distribution
Distributed nationwide across the United States.
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