FDA Recall Terminated

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.

Recall: Z-0456-2019 · Initiated December 28, 2016

Recall

Recall Number
Z-0456-2019
Event Number
80754
Firm
American Contract Systems, Inc.
FEI Number
3003419114
Product Code
KGO
Status
Terminated
Root Cause
Other
Initiated
December 28, 2016
Terminated
November 14, 2018
Address
2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648

Description

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.

Reason

Powdered Surgical Gloves are an FDA banned substance.

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: [email protected].

Distribution

US Distribution to states of: IL, MO, NE, and OH.

Quantity

1,180 kits