Z-0638-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- October 31, 2018
- Termination Date
- August 12, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,475,095 pairs total
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.
Distribution Pattern
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.
Code Information
Product code: 2D73DP90, Lot Numbers: TS18060016, TS18070126, TS18070315, TS18080353, and TS18090220.