Food, drugs, devices › ASO, LLC
Device recall: CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909
ASO, LLC (Sarasota, FL) initiated this device recall on 26 Jul 2013; FDA lists 9 product records under event 65819, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 4 Aug 2014. Initiation: voluntary: firm initiated. ASO, LLC has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ASO, LLC, Sarasota, FL.
Reason for recall
"This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility."
Distribution
"Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
| 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. | Total 2,689,560 pouches (2 cards/pouch) | Class II | Terminated | 14 Aug 2013 |
Context
Other enforcement events for ASO, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Mar 2023 | WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack A | Device | Class II | 1 |
| 22 Jun 2022 | (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU | Device | Class II | 1 |
| 2 Mar 2022 | First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon) | Device | Class II | 1 |
| 16 Oct 2018 | Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauz | Device | Class II | 1 |
| 10 Jun 2015 | Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes | Device | Class II | 1 |
| 21 Aug 2013 | SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Aug 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.