—#137341

Product

BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: 3038787 3046210 3061080 3078492 3093681 3095940 3108668

Why it was recalled

Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Beaver-Visitec International Sales Ltd. (BVI) sent an Urgent Field Safety Notice dated May 2, 2015, to all affected customers. Customers were instructed to quarantine the affected kits and return to BVI for subsequent replacement of product. A Verification Form was provided to confirm receipt of the recall notice. For questions regarding this recall call 791-906-7950.

Recalling firm

Firm: Beaver-Visitec International Inc.
Address: 411 Waverley Oaks Rd, Ste 229, Waltham, Massachusetts 02452-8422

Distribution

Distribution pattern: Nationwide Distribution including KY, GA, MI, and NJ.

Timeline

Recall initiated: 2015-05-01
Posted by FDA: 2015-06-15
Terminated: 2021-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.