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Aso LLC

Sarasota, FL, US

ASO LLC appears in FDA device records in Sarasota, FL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
15
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Aso LLC between 1993 and 1999. The busiest year on record is 1993, with 2. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Aso LLC, by decision year
YearClearances
19932
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K983368CARE BAND ANTIBACTERIAL BANDAGESKGXSubstantially Equivalent
K933159XYZ PADSEFQSubstantially Equivalent
K932602ADHESIVE BANDAGESKGXSubstantially Equivalent

Registered establishments

FDA registered establishments for Aso LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10387581038758ASO LLC300 SARASOTA CENTER BLVD., SARASOTA, FL 34240 US2026and 17 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1499-2023WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.Class IIOpen, Classified
Z-1517-2022(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.The product falls apart during handling after removal from its primary packaging.Class IIOpen, Classified
Z-1031-2022First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)Kits contained recalled acetaminophen.Class IITerminated
Z-0525-2019Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard boxPotential that gauze pads may not be fully sterilizedClass IIOpen, Classified
Z-2460-2015Carepak 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 active ingredient in the product label.Class IITerminated
Z-0004-2014SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.No antibacterial bandages were packed in boxes labeled as antibacterial.Class IITerminated
Z-1896-2013Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1895-2013TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1894-2013Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1893-2013Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1892-2013Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1891-2013HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1890-2013Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1889-2013Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated
Z-1888-2013CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain