Recall Z-0720-2022 ยท OCT Anti Fog Solution And Accessories, Endoscopy
Sunstar Americas, Inc.
BUTLER Clear Dip, 12 bottles/case
| Date | Jan 14, 2022 |
| Status | Terminated |
| Reason | Product lacks premarket clearance. |
| Root cause | No Marketing Application |
| Action | A Recall Letter is being sent to all direct consignees who have received impacted product via USPS First Class mail The Recall Letter will be posted to the corporate web site at www.gumbrand.com Customers are instructed as follows: 1. Please examine your inventory to determine if you have any of the affected product lots 2. Please call 1-800-528-8537 or email: us.pcr@us.sunstar.com with the results of your inventory check (even if the affected lots are no longer in inventory), and if affected lots are present, provide the lot numbers, quantities, and a recall contact. 3. Complete the enclosed |
| Quantity | 22514 ea |
| Distribution | United States Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.