Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
This recall has been terminated (originally issued January 9, 2017).
- Recall Initiated
- January 9, 2017
- Terminated
- September 28, 2018
- Recall Number
- Z-1594-2017
- Quantity
- 15 kits
- Firm Location
- Springfield, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Distribution
US Distribution to LA and TX.
Lot / Code Info
039418C Exp Date 2018-11-04; 040012C Exp Date 2018-12-05;
Root Cause
Nonconforming Material/Component
Action Taken
ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.