CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report
Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes recalled
ASO is recalling Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes, distributed in Rhode Island. The recall was initiated on 10 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2460-2015
- FDA event ID
- 71682
- Recalling firm
- ASO, Sarasota, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2015
- FDA classified
- 25 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2015 | Recall initiated by company | |
| 25 Aug 2015 | Classified by FDA | +76 days |
| 2 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
Where it was distributed
US Distribution to Rhode Island only
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model #141168; Lots #s 00013359, 00020722 and 00028721.
Where was it sold?
US Distribution to Rhode Island only
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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