Aso, LLC

Medical device manufacturer in Sarasota, FL.

4510(k) clearances
0PMA approvals
15recalls

Device types

510(k) clearances

510(k)DeviceDecision
K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesFRO · Traditional 06/17/2009SE
K983368Care Band Antibacterial BandagesKGX · Traditional 02/17/1999SE
K933159Xyz PadsEFQ · Traditional 12/13/1993SE
K932602Adhesive BandagesKGX · Traditional 08/09/1993SE

Recalls

RecallProductInitiated
Z-1499-2023 Class IIWALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping…The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the… 03/23/2023Open, Classified
Z-1517-2022 Class II(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in.…The product falls apart during handling after removal from its primary packaging. 06/22/2022Open, Classified
Z-1031-2022 Class IIFirst Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and…Kits contained recalled acetaminophen. 03/02/2022Terminated
Z-0525-2019 Class IIFamily Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached…Potential that gauze pads may not be fully sterilized 10/16/2018Open, Classified
Z-2460-2015 Class IICarepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted SizesContain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an… 06/10/2015Terminated
Z-0004-2014 Class IISHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and…No antibacterial bandages were packed in boxes labeled as antibacterial. 08/21/2013Terminated
Z-1896-2013 Class IIWalgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1895-2013 Class IITopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1894-2013 Class IIPremier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in.…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1893-2013 Class IIMeijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1892-2013 Class IILeader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1891-2013 Class IIHEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1890-2013 Class IIDuane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in.…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1889-2013 Class IIDiscount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in.…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated
Z-1888-2013 Class IICVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in.…This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. 07/26/2013Terminated