FDA Device

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.

Hazard

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

What You Should Do

Remedy

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.

Products

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 box
Brand
Dynarex Corporation
UPC
Lot 15860 (recall letter 5/07/04). UPDATE: Lots 15901 & 15706 (recall letter 5/20/04)

Units Affected

50 cases (Lot 15860); 166 cases (lots 15901, 15706)