DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Reported: April 13, 2022 Initiated: March 3, 2022 #Z-0879-2022
Product Description
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Reason for Recall
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 780 kits
- Distribution
- US distribution to Florida, New Jersey, and Tennessee
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.. Recalled by DeRoyal Industries Inc. Units affected: 780 kits.
Why was this product recalled? ▼
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0879-2022.
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