Z-2458-2015Class II

Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended...

Name: Z-2458-2015 Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended...
Creator: Medline Industries Inc
Published: 2015-08-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2015-08-03 / Terminated / root cause: labeling and UDI

FDA source

Medline Industries Inc began a recall of Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age... on 2015-08-03. FDA classified it as Class II and gives the reason as "The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The...". 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-2458-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-03
Posted: 2015-08-25
Terminated: 2017-01-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
Product code: OFF Central Venous Catheter Tray
Reason for recall: The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Medline Industries contacted the account directly via phone on August 4, 2015, they confirmed no affected product is in their facility. The lot numbers are easily identified on the outside of each kit. Second and third follow up communications will not be sent as we have confirmed the facility does not have any affected product. For questions regarding this recall call 847-643-4129.
Quantity in commerce: 320 units for lot 14DB9277 & 320 units for lot 14PB2878
Distribution: US including PA
Product codes and lots: Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected. Lot Numbers: 14DB9277 and 14PB2878 Unit No: DYNDC1987A Expiration Date: 06/2015 Serial No: N/A UPC code: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2458-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2458-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-25

Product code OFF

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)