Recall Z-1088-2019 ยท HNN Knife, Ophthalmic
Beaver Visitec
Micro Knife 5.0mm 30, Part Number 0001522 The Beaver Micro Knife 5.0mm 30 is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .
| Date | Feb 19, 2019 |
| Status | Terminated |
| Reason | The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct. |
| Root cause | Error in labeling |
| Action | The firm, Beaver-Visitec International, Inc, sent an "URGENT: MEDICAL DEVICE RECALL" notification letter dated 2/19/19 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately examine your inventory and quarantine product from this lot subject to recall. If you have further distributed this product, please identify your customers and notify them of this product recall. Consider all potential users of this product in your user supply chain. 2. Complete and return the enclosed Product Recall Notice Response |
| Quantity | 97 boxes (10units/box) |
| Distribution | US Nationwide Distribution to states of : AL, AZ, CA, FL, ID, MN, MO, NY, OH, PA, and TX; and internationally to: Ireland and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.