Recall Z-2029-2012 ยท FST Light, Surgical, Fiberoptic
Gulf Fiberoptics, Inc.
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
| Date | Jul 18, 2012 (initiated Apr 9, 2012) |
| Status | Terminated |
| Reason | The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference. |
| Root cause | Device Design |
| Action | The firm, Gulf Fiberoptics, Inc., sent an "RECALL NOTIFICATION-PLEASE DO NOT DISCARD" letter dated April 09, 2012 to its customer via (traceable letter & email). A notification was put on the firm's website. The letter described the product, problem and actions to be taken. The distributors were instructed to determine the status of the product; remove existing product from service immediately and return to their company in a timely manner; send all returned GMF-RC65 cables to Gulf Fiberoptics; forward copies of the recall letters to their customers, ultimately the end user, and complete and r |
| Quantity | 169 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX and WI and country of: South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.