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) 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
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1999 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1038758 | 1038758 | ASO LLC | 300 SARASOTA CENTER BLVD., SARASOTA, FL 34240 US | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FQMBandage, Elastic
- MGOClosure, Wound, Adhesive
- LWFDilator, Nasal
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- FRLFiber, Medical, Absorbent
- LRRFirst Aid Kit With Drug
- OHOFirst Aid Kit Without Drug
- GENForceps, General & Plastic Surgery
- NABGauze / Sponge,Nonresorbable For External Use
- EFQGauze/Sponge, Internal
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- LKBPad, Alcohol, Device Disinfectant
- HMPPad, Eye
- LZAPolymer Patient Examination Glove
- LRWScissors, General, Surgical
- ILISling, Arm
- ILHSplint, Hand, And Components
- FPXStrip, Adhesive, Closure, Skin
- KGXTape And Bandage, Adhesive
- GEHUnit, Cryosurgical, Accessories
- LYZVinyl Patient Examination Glove
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1499-2023 | WALGREENS 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 II | Open, 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 II | Open, Classified | |
| Z-1031-2022 | First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon) | Kits contained recalled acetaminophen. | Class II | Terminated | |
| Z-0525-2019 | Family 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 box | Potential that gauze pads may not be fully sterilized | Class II | Open, Classified | |
| Z-2460-2015 | Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes | Contain 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 II | Terminated | |
| Z-0004-2014 | SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. | No antibacterial bandages were packed in boxes labeled as antibacterial. | Class II | Terminated | |
| Z-1896-2013 | Walgreens ("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 II | Terminated | |
| Z-1895-2013 | TopCare 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 II | Terminated | |
| Z-1894-2013 | Premier 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 II | Terminated | |
| Z-1893-2013 | Meijer 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 II | Terminated | |
| Z-1892-2013 | Leader 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 II | Terminated | |
| Z-1891-2013 | HEB 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 II | Terminated | |
| Z-1890-2013 | Duane 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 II | Terminated | |
| Z-1889-2013 | Discount 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 II | Terminated | |
| Z-1888-2013 | CVS 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 II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain
