Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight recall: Sterility Concern
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Why was Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight recalled?
Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035
- Product
- Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
- Recalling firm
- Beaver Visitec International, Inc.
- Quantity
- 599 units (US): 410 units; 189 kits
- Distribution
- US Nationwide distribution.
- Recall date
- January 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)