Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on pa

FDA device recall Z-2458-2015 · posted 2015-08-25 · Terminated

Recall details

Recalling firm

Medline Industries Inc

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.

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

OFF

Quantity affected

320 units for lot 14DB9277 & 320 units for lot 14PB2878

Distribution

US including PA

Date initiated

2015-08-03

Date posted

2015-08-25

Date terminated

2017-01-05

Location

Mundelein, IL