DeRoyal DEXMED Access Center Tray Recalled for Manufacturing Test Validation Uncertainty
DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device used for surgical and injection site preparation. Uncertain validation of manufacturing test methods creates a risk-of-harm scenario for patient safety at vulnerable clinical sites, even without reported illnesses.
Plain-English summary
DeRoyal Industries Inc is recalling 1,360 DEXMED ACCESS CENTER TRAY kits containing Prevantics antiseptic swabs (chlorhexidine gluconate and isopropyl alcohol) used for skin preparation prior to surgery or injection procedures. The recall was initiated due to uncertain validation of the test methods used to manufacture the product.
The affected kits are identified by part number 89-5300.07 and UDI 00749756632317. Eight lot numbers are included in the recall, all with an expiration date of June 1, 2022: Lots 53059743, 53632941, 53666113, 54205909, 54279422, 54327332, 54473313, and 55573404. The kits were distributed to healthcare facilities in Florida, New Jersey, and Tennessee.
Healthcare facilities should verify whether they have received any of the affected lot numbers and take appropriate action regarding the recalled product.
The recalled product
- Product
- 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.
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 1,360
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- SKU/Part Number 89-5300.07
- Lot 53632941 (exp 06/01/2022)
- Lot 53666113 (exp 06/01/2022)
- Lot 54205909 (exp 06/01/2022)
- Lot 54279422 (exp 06/01/2022)
- Lot 54327332 (exp 06/01/2022)
- Lot 54473313 (exp 06/01/2022)
- Lot 55573404 (exp 06/01/2022)
Distribution
Part of a larger recall action
This product is one of 3 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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