—#169229

Product

Protexis Neoprene Surgical Glove, Size 8.5 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.

FDA product code: KGO — Surgeon'S Gloves
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K113707
Affected lot / code info: Product code: 2D73DP85, Lot Numbers: TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, and TS18090219.

Why it was 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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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).

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

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.

Timeline

Recall initiated: 2018-10-31
Terminated: 2025-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.