Z-2460-2015Class II

Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes

Name: Z-2460-2015 Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
Creator: Aso, Llc
Published: 2015-06-10
License: https://open.fda.gov/license/

Aso LLC / initiated 2015-06-10 / Terminated / root cause: manufacturing process

FDA source

ASO, LLC began a recall of Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes on 2015-06-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2460-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-10
Posted: 2015-08-25
Terminated: 2016-10-12
Recalling firm: Aso LLC
Product: Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 655 cases.
Distribution: US Distribution to Rhode Island only
Product codes and lots: Model #141168; Lots #s 00013359, 00020722 and 00028721.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2460-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2460-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-25

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)