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.
- Company
- Dynarex Corporation
- Recall Initiated
- May 10, 2004
- Posted
- July 20, 2004
- Terminated
- August 30, 2012
- Recall Number
- Z-0951-04
- Quantity
- 50 cases (Lot 15860); 166 cases (lots 15901, 15706)
- Firm Location
- Orangeburg, NY
Reason for Recall
Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
Distribution
Medical supply distributors located in NY, NJ, PA, TX, MN, GA, FL, MI, OH, IL, MS, KY, AZ , CA, NV, CO, and Puerto Rico, for further distribution to their customers. --- UPDATE: There were 2 foreign accounts in Panama that received the additional lots. The additional lots were distributed to the aforementioned states plus the following states: MA, MO, ME, VA, NC, LA.
Lot / Code Info
Lot 15860 (recall letter 5/07/04). UPDATE: Lots 15901 & 15706 (recall letter 5/20/04)
Root Cause
Other
Action Taken
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.