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.
Check against the official notice below — it lists the full affected range.
DeRoyal Industries Inc. recalled the DeRoyal DEXMED ACCESS CENTER TRAY, a surgical skin preparation kit containing a PDI Prevantics antiseptic swab (chlorhexidine gluconate and isopropyl alcohol). The recall was issued because the PDI Prevantics Swab component had uncertain validation of the test methods used during manufacturing. A total of 1,360 kits were distributed in the United States to Florida, New Jersey, and Tennessee.
The recalled kits were identified by SKU/Part Number 89-5300.07 and include eight lot numbers all with June 1, 2022 expiration dates: 53059743, 53632941, 53666113, 54205909, 54279422, 54327332, 54473313, and 55573404. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Reason for recall: A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. Distribution: US distribution to Florida, New Jersey, and Tennessee Quantity: 1360 kits Lot/code info: SKU/Part Number 89-5300.07; UDI 00749756632317 Lot Numbers (Expiration Date): Lot 53059743 (exp 06/01/2022), 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.