Recall Z-0635-2019
Cardinal Health 200, LLC · initiated October 31, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Protexis Neoprene Surgical Glove, Size 7.5 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.
Codes / lots: Product code: 2D73DP75, Lot Numbers: TS18060009, TS18060145, TS18060251, TS18060322, TS18070037, TS18070122, TS18070312, TS18070380, TS18080033, TS18080350, TS18090125, TS18090154, TS18090213, and TS18090290.
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: Labeling mix-ups
Action taken
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).
Details
- Recall number
- Z-0635-2019
- Initiated
- October 31, 2018
- Terminated
- August 12, 2025
- Product code
- KGO – Surgeon'S Gloves
- Quantity
- 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…
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0631-2019 Class II | Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | 10/31/2018Terminated |
| Z-0632-2019 Class II | Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | 10/31/2018Terminated |
| Z-0633-2019 Class II | Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | 10/31/2018Terminated |
| Z-0634-2019 Class II | Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | 10/31/2018Terminated |
| Z-0636-2019 Class II | Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | 10/31/2018Terminated |
| Z-0637-2019 Class II | Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | 10/31/2018Terminated |
| Z-0638-2019 Class II | Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | 10/31/2018Terminated |