Recall Z-0456-2019— American Contract Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2016-12-28, terminated 2018-11-14. FDA's recall record names no specific 510(k) clearance for this event. 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: Powdered Surgical Gloves are an FDA banned substance..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-28
- Terminated
- 2018-11-14
- Firm location
- Kansas City, MO, United States
Product 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 for recall
Powdered Surgical Gloves are an FDA banned substance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.