FDA recall Z-0456-2019

American Contract Systems, Inc. · Class II · device

Product

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 for recall

Powdered Surgical Gloves are an FDA banned substance.

Distribution

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

Key facts

Status
Terminated
Initiation date
2016-12-28
Report date
2018-11-21
Termination date
2018-11-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0456-2019