Medline Industries Inc: Medical Device Recall in 2015 - (Recall #: Z-2458-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 3, 2015

Date Posted: September 2, 2015

Recall Number: Z-2458-2015

Event ID: 71889

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.

Status: Terminated

Product Quantity: 320 units for lot 14DB9277 & 320 units for lot 14PB2878

Code Information:

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

Distribution Pattern:

US including PA

Voluntary or Mandated:

Voluntary: Firm initiated