Dynarex Corporation 100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- Device Listing # E177598. 510(k) Exempt. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.

Recommended Action

Per FDA guidance

Recall letters & response forms were sent to the consignees on 5/10/04 via Certified Mail, Return Receipt Requested. On 5/24/04, a second recall letter & response form were mailed via Certified Mail to the 60 distributors that received the 2 additional lots being recalled.

Distribution

As reported by FDA

AZ, CA, CO, FL, GA, IL, IN, KY, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NY, NC, OH, PA, TX, VA, PR