Xstar Safety Slit Knife Recalled for Incorrect Blade Configuration
Beaver Visitec International is recalling 126 Xstar Safety Slit Knives with incorrect blade configuration. The recalled knives have the bevel oriented to the back instead of the front.
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 risk-of-harm surgical device with a critical configuration defect where the blade orientation is reversed. No injuries or illnesses have been reported, which places it under the rubric category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beaver Visitec International, Inc. is recalling 126 Xstar Safety Slit Knife units (Model Number 378227) due to incorrect blade configuration. The recalled knives are components of CustomEye Kits and were packaged with the blade bevel on the back (bevel down) instead of the intended front position (bevel up).
The affected products have been distributed worldwide, including in the United States, Canada, the United Kingdom, and Italy. The recalled items can be identified by the following lot numbers: Xstar Safety Slit Knife Lot Number 6058854 (UDI-DI 00886158001652), CustomEye Kit #584562 Lots 6068524 and 6068025, and CustomEye Kit #5800109 Lot 6068285.
The recalled product
- Product
- Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- blade-configuration-defect
- manufacturing-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)
- Xstar Safety Slit Knife: UDI-DI: 00886158001652
- Lot Number: 6058854
- CustomEye Kit # 584562
- lot # 6068524
- lot # 6068025
- CustomEye Kit # 5800109
- lot # 6068285
Distribution
Distributed nationwide across the United States.
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