ASO LLC

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1499-2023Class IIWALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), WalMarch 23, 2023
Z-1517-2022Class II(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO IJune 22, 2022
Z-1031-2022Class IIFirst Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care ScienceMarch 2, 2022
Z-0525-2019Class IIFamily Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayonOctober 16, 2018
Z-2460-2015Class IICarepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted SizesJune 10, 2015
Z-0004-2014Class IISHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.August 21, 2013
Z-1889-2013Class IIDiscount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile lJuly 26, 2013
Z-1896-2013Class IIWalgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 July 26, 2013
Z-1888-2013Class IICVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex fJuly 26, 2013
Z-1890-2013Class IIDuane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latJuly 26, 2013
Z-1894-2013Class IIPremier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex July 26, 2013
Z-1891-2013Class IIHEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPJuly 26, 2013
Z-1893-2013Class IIMeijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free July 26, 2013
Z-1895-2013Class IITopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free July 26, 2013
Z-1892-2013Class IILeader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free July 26, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K082910CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGESJune 17, 2009
K983368CARE BAND ANTIBACTERIAL BANDAGESFebruary 17, 1999
K933159XYZ PADSDecember 13, 1993
K932602ADHESIVE BANDAGESAugust 9, 1993