IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ou
FDA device recall Z-2089-2016 · posted 2016-06-29 · Terminated
Recall details
- Recalling firm
- CMP Industries, Llc
- Reason for recall
- Possible presence of foreign material (rust).
- Action taken
- CMP Industries/Nobilium sent an Urgent IMPAK Recall letter dated March 2, 2016, to all affected customers via certified mail with return receipt in an attempt to verify if customers were in possession of the affected product. Customers were advised to immediately examine inventory and to quarantine product subject to the recall. In addition, if customers further distributed the product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the notice. If customers have any of the product in their posession subject to recall, please contact the firm by calling 518-434-3147, ext 144, Monday - Friday 8-4:30 pm, EST.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- EBI
- Quantity affected
- 236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)
- Distribution
- Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
- Date initiated
- 2016-03-02
- Date posted
- 2016-06-29
- Date terminated
- 2017-03-16
- Location
- Albany, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPAK ACRYLIC REPAIR RESIN LIQUID (K033020) | Cmp Industries, LLC | 2003-12-19 |