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U.S. Department of Health and Human Services

Class 2 Device Recall Neoprene Surgical Gloves

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  Class 2 Device Recall Neoprene Surgical Gloves see related information
Date Initiated by Firm October 31, 2018
Create Date December 19, 2018
Recall Status1 Open3, Classified
Recall Number Z-0633-2019
Recall Event ID 81579
510(K)Number K113707  
Product Classification Surgeon's gloves - Product Code KGO
Product Protexis Neoprene Surgical Glove, Size 6.5

This powder-free Surgeon s glovessterile 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.
Code Information Product code: 2D73DP65, Lot Numbers: TS18050409, TS18060149, TS18060240, TS18060312, TS18070036, TS18070106, TS18070306, TS18070371, TS18080026, TS18080348, TS18080445, TS18090113, TS18090159, TS18090212, and TS18090282. 
Recalling Firm/
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
Labeling mix-ups
Action Cardinal Health notified customers on about 10/31/2018 via "URGENT: PRODUCT CORRECTION NOTICE." Customers were instructed to examine inventory for affected products, affix the provided warning label on the principal display panel on the affected dispenser packs, notify internal parties and/or customers if the product was further distributed of the recall, and complete and return the provided Acknowledgement Form. If the wallets containing the gloves are removed from the dispenser packs, customers were also instructed to provide a warning label to accompany the affected product inform users of the correct breakthrough times. If customers need additional labels, they were instructed to contact 800-292-9332 or gmb-fieldcorrectiveaction@cardinalhealth.com for assistance. For further questions regarding the Product Correction Notice, please reference the following Customer Service telephone numbers: Hospital (800-964-5227), Federal Government (800-444-1166), Distributor (800-635-6021), All other customers (888-444-5440).
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KGO and Original Applicant = CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES