Z-1310-2010

Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The...

Name: Z-1310-2010 Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The...
Creator: Aplicare, Inc.
Published: 2010-03-03
License: https://open.fda.gov/license/

Aplicare, Inc. / initiated 2010-03-03 / Terminated / root cause: labeling and UDI

FDA source

Aplicare, Inc. began a recall of Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change on 2010-03-03. The reason FDA records is "Incorrect expiration date on outer kit label-extended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1310-2010
Status: Terminated
Initiated: 2010-03-03
Posted: 2010-04-08
Terminated: 2012-03-16
Recalling firm: Aplicare, Inc.
Product: Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change.
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: Incorrect expiration date on outer kit label-extended.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 103 cases (20 each)
Distribution: United States (CT, RI, NJ and OH).
Product codes and lots: Lot number: 35397.

Product code NAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)