Recall Z-1310-2010

Aplicare, Inc. · initiated March 3, 2010

Terminated

Product

Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change.

Codes / lots: Lot number: 35397.

Reason for recall

Incorrect expiration date on outer kit label-extended.

FDA-determined cause: Error in labeling

Action taken

Aplicare notified customers by telephone on March 3, 2010 followed with "Product Recall Notice" letter issued by e-mail to the distributor level. Product will be labeled with correct expiration date. Direct questions to your sales representative or customer service by calling 1-800-760-3236.

Details

Recall number
Z-1310-2010
Initiated
March 3, 2010
Posted by FDA
April 8, 2010
Terminated
March 16, 2012
Product code
NAD – Dressing, Wound, Occlusive
Quantity
103 cases (20 each)
Distribution
United States (CT, RI, NJ and OH).
Recalling firm
Aplicare, Inc., Meriden, CT

Official FDA recall record