Atlas FDA

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

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
IMPAK ACRYLIC REPAIR RESIN LIQUID (K033020)Cmp Industries, LLC2003-12-19