Recalls / —

—#162177

Product

PEDIATRIC IV & IV START KIT

FDA product code

LRP — Tray, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

IV5785 IV6135  Lot codes: 2015121890 2016031490 2016102490 2016111490 2017012390 2017050890 2016071190 2015101990 2015120790 2016010490 2016012590 2016101090 2017010290 2017061990 2017071090

Why it was recalled

Convenience Kit containing components to assist practitioner with IV placement and securement.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.

Recalling firm

Firm

Centurion Medical Products Corporation

Address

100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern

Nationally

Timeline

Recall initiated

2017-10-23

Terminated

2018-06-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #162177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.