Sklar Instruments Recalls Sterile Vein Hooks Due to Packaging Issues
Sklar Instruments is recalling 1,050 units of ECONO STERILE Vein Hooks due to packaging issues that may breach the sterile barrier. Products were distributed nationwide.
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 Class II medical device recall for sterile surgical instruments, a risk-of-harm product. The source describes packaging issues that may result in sterile barrier breach but reports no illnesses or injuries. Per the rubric, a risk-of-harm product without reported injury scores at most 3 (High).
Plain-English summary
Sklar Instruments is recalling 1,050 units of ECONO STERILE Vein Hooks (Models 96-4020M, 96-4021M, and 96-4022M).
The recall is due to reports of packaging issues that may result in a breach of the sterile barrier.
The affected products were distributed nationwide. Affected lot codes include SK-125 and SK-128.
Healthcare providers should stop using affected kits and contact Sklar Instruments. Patients who may have received procedures with these instruments should consult their healthcare provider.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous proced
- Manufacturer
- Sklar Instruments
- Affected units
- 1,050
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 (9)
- 1) 96-4020M
- UDI/DI 50649111476356
- Lot codes: SK-125
- 2) 96-4021M
- UDI/DI 50649111476363
- SK-128
- 3) 96-4022M
- UDI/DI 50649111476370
- Lot codes: SK-125.
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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