Recall Z-1803-2015— Beaver-Visitec International Inc.
Class II · Terminated
Class II FDA medical device recall by Beaver-Visitec International Inc., initiated 2015-05-01, terminated 2021-01-28. FDA's recall record names no specific 510(k) clearance for this event. Product: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits. Reason: Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product.
- Recalling firm
- Beaver-Visitec International Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-01
- Terminated
- 2021-01-28
- Firm location
- Waltham, MA, United States
Product description
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Reason for recall
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Data sourced from openFDA. This site is unofficial and independent of the FDA.