Recall Z-0456-2019 ยท KGO Surgeon'S Gloves
American Contract Systems, Inc.
Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.
| Date | Dec 28, 2016 |
| Status | Terminated |
| Reason | Powdered Surgical Gloves are an FDA banned substance. |
| Root cause | Other |
| Action | The firm, ACS, notified Customers via phone call and email on about 12/28/2016. The customers were informed about the product, problem and actions to be taken. The customers were instructed to identify and remove all the affected kits for replacement of the recalled gloves; tray insert label must reflect the omission of the powered gloves; and ban, quarantine and return affected product. If you have any questions, contact that Quality Manager at 816-920-5846 or email to: tbakke@amconsys.com. |
| Quantity | 1,180 kits |
| Distribution | US Distribution to states of: IL, MO, NE, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.