ClearanceBrief
Recall Z-1310-2010 ยท NAD Dressing, Wound, Occlusive

Aplicare, Inc.

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

DateApr 8, 2010 (initiated Mar 3, 2010)
StatusTerminated
ReasonIncorrect expiration date on outer kit label-extended.
Root causeError in labeling
ActionAplicare 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.
Quantity103 cases (20 each)
DistributionUnited States (CT, RI, NJ and OH).
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.