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FDA device recall Z-2055-2015 · posted 2015-07-09 · Terminated

Recall details

Recalling firm

Volk Optical Inc

Reason for recall

Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.

Action taken

Volk Optical sent a Medical Device Recall letter on March 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product. If product was further distributed customers need to identify their customers and notify them at once. Customers were instructed to return the affected device for replacement. Customers with questions were instructed to contact Volk at 440-942-6161 or toll free at 800-345-8655. For questions regarding this recall call 440-510-0745.

Root cause

Other

Status

Terminated

Product code

HJI

Quantity affected

78 units

Distribution

Distribution to VA only

Date initiated

2015-02-27

Date posted

2015-07-09

Date terminated

2016-02-04

Location

Mentor, OH