Recall Z-2460-2015 ยท KGX Tape And Bandage, Adhesive
ASO, LLC
Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
| Date | Aug 25, 2015 (initiated Jun 10, 2015) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.