Recall Z-0523-2018 ยท FTA Light, Surgical, Accessories
Ecolab, Inc.
Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting syst
| Date | Oct 13, 2017 |
| Status | Terminated |
| Reason | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. |
| Root cause | Under Investigation by firm |
| Action | Ecolab sent and Urgent Medical Device Recall letter dated October 13, 2017 to customers. The identified the affected product, problem and actions to be taken. Instructions include to immediately quarantine lots in inventory, notify customers since the product has been further distributed, return affected product, and complete and return the Recall Response Form. For questions call 903-597-2568. |
| Quantity | 5,958 cases (50 per case) |
| Distribution | Distributed domestically to Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.