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U.S. Department of Health and Human Services

Class 2 Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages

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  Class 2 Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages see related information
Date Initiated by Firm May 10, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 30, 2012
Recall Number Z-0951-04
Recall Event ID 29031
Product Classification Bandage, Elastic - Product Code FQM
Product 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.
Code Information Lot 15860 (recall letter 5/07/04). UPDATE: Lots 15901 & 15706 (recall letter 5/20/04)
Recalling Firm/
Manufacturer		 Dynarex Corporation
10 Glenshaw Street
Orangeburg NY 10962-1207
For Additional Information Contact Mr. Jim Hurlman
845-365-8200
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 50 cases (Lot 15860); 166 cases (lots 15901, 15706)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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