PlainRecalls
FDA Devices Moderate Class II Terminated

Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Reported: December 26, 2018 Initiated: October 31, 2018 #Z-0638-2019

Product Description

Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Reason for Recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
1,475,095 pairs total
Distribution
Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.. Recalled by Cardinal Health 200, LLC. Units affected: 1,475,095 pairs total.
Why was this product recalled?
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0638-2019.