Beaver Surgical Eye Knife Recalled for Sterile Barrier Compromise
Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.
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: FDA Class II recall for compromised sterile packaging on a surgical device used in eye procedures. The hazard presents a risk of infection, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
Beaver Visitec International, Inc. is recalling the Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G), Part Number 376630. This surgical instrument is used for ocular paracentesis incisions during cataract procedures. The recall affects 599 units distributed nationwide in the US, consisting of 410 individual units and 189 kits. The affected lot number is 3391035. Some units were packaged as components of the READYPAK KIT (Cat. 584896, Lots 6054175 and 6053035).
The device is being recalled due to a compromised packaging sterile barrier. Open seals can result in a loss of device sterility and may lead to infection.
This recall affects healthcare facilities and surgical centers throughout the US. Providers and facilities should verify their inventory using the provided lot numbers. Patients who have undergone cataract procedures and are concerned about potential exposure should contact their healthcare provider.
The recalled product
- Product
- Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- sterility-loss
- infection-risk
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 (1)
- 6053035
Distribution
Distributed nationwide across the United States.
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