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U.S. Department of Health and Human Services

Class 2 Device Recall Central Lane, 34 weeks

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  Class 2 Device Recall Central Lane, 34 weeks see related information
Date Initiated by Firm August 03, 2015
Date Posted August 25, 2015
Recall Status1 Terminated 3 on January 05, 2017
Recall Number Z-2458-2015
Recall Event ID 71889
Product Classification Central venous catheter tray (kit) - Product Code OFF
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.
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 
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4485
For Additional Information Contact Dale Greeson
847-643-4129
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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