100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg,
FDA device recall Z-0951-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Dynarex Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FQM
- Quantity affected
- 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 a
- Date initiated
- 2004-05-10
- Date posted
- 2004-07-20
- Date terminated
- 2012-08-30
- Location
- Orangeburg, NY
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