DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Recall
- Recall Number
- Z-0880-2022
- Event Number
- 89737
- Firm
- DeRoyal Industries Inc
- FEI Number
- 1043214
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 3, 2022
- Terminated
- September 15, 2022
- Address
- 200 Debusk Ln, Powell, TN, 37849-4703
Description
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
DeRoyal issued their recall on March 3, 2022 to the end user level by mailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the product and the notice of return form that was provided back to DeRoyal.
US distribution to Florida, New Jersey, and Tennessee
1360 kits