Z-2458-2015 Class II Terminated
FDA device recall Z-2458-2015 was initiated by Medline Industries Inc on Aug 3, 2015 and is designated Class II. 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… The recall status is terminated (terminated Jan 5, 2017). Affected quantity: 320 units for lot 14DB9277 & 320 units for lot 14PB2878.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 2, 2015
- Initiation Date
- Aug 3, 2015
- Termination Date
- Jan 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320 units for lot 14DB9277 & 320 units for lot 14PB2878
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.
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.
Distribution Pattern
US including PA
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2458-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026