Recalls / —

—#162178

Product

IV START KIT

FDA product code

LRP — Tray, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

IV6860 IVS1345  Lot codes: 2015110290 2016011190 2016030790 2016050290 2016061390 2016081590 2016101090 2017010290 2017021390 2017032090 2017050890 2017071790 2015110990 2016020890 2016062090 2016071190 2016072590 2016080890 2016082990 2016090590 2016091990

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 #162178. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.