FDA Medical Device Recalls (openFDA)
ASO, LLC: Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
- Recall number
- Z-2460-2015
- Recalling firm
- ASO, LLC
- Product
- Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
- Status
- Terminated
- Initiated
- 2015-06-10
- Posted
- 2015-08-25
- Terminated
- 2016-10-12
- Reason
- 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.
- Root cause
- Process control
- Action
- Customers were contacted by phone and e-mail on 06/10/2015; First class letter was sent on 06/23/2015.
- Quantity
- 655 cases.
- Distribution
- US Distribution to Rhode Island only
- Lot, serial or model codes
- Model #141168; Lots #s 00013359, 00020722 and 00028721.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGX
- Firm FEI
- 1038758
- Firm city
- Sarasota
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28