Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM9
FDA device recall Z-0712-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Adenna Inc
- Reason for recall
- The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
- Action taken
- Adenna Inc. sent a recall letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and quarantine the products that are subject to the recall. Customers were instructed to notify their customers if they have further distributed the products. Customers were instructed to cease using the recalled products, and Adenna will replace the products. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with any questions can contact their account manager at (888) 3ADENNA (1-888-323-3662) for futher assistance.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- LYY
- Quantity affected
- 427 cartons
- Distribution
- Nationwide Distribution including the states of: FL, CA, NY, NV, NC, MD, TX, OR, AZ, OH, MN, and IL.
- Date initiated
- 2011-12-22
- Date posted
- 2012-01-11
- Date terminated
- 2012-05-29
- Location
- Ontario, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN (K100694) | Tekmedic (M) Sdn Bhd | 2010-06-25 |