Recall Z-2162-2024— Beaver Visitec International, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2024-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109. Reason: The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down)..
- Recalling firm
- Beaver Visitec International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-10
- Firm location
- Waltham, MA, United States
Product description
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
Reason for recall
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
Data sourced from openFDA. This site is unofficial and independent of the FDA.