Device product
Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
Z-2460-2015
Product summary
- Firm
- ASO, LLC
- Event
- Event 71682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 655 cases.
- Official record key
device-enforcement:Z-2460-2015
Official wording
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.
Code information: Model #141168; Lots #s 00013359, 00020722 and 00028721.
Distribution pattern: US Distribution to Rhode Island only
Derived failure modes
-
Unknown
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.