Recall record at a glance
| Official record | Z-0500-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Beaver-Visitec International Inc. |
| Report date | Feb 7, 2018 |
| Recall initiation date | Nov 3, 2017 |
| Quantity | 45, 680 units |
| Location | Waltham, MA, United States |
Official product description
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Why the product was recalled
The protective shield was retracted, and the blade was exposed.
Distribution information
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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