Recalls / —

—#162176

Product

LATEX FREE IV START SET

FDA product code

LRP — Tray, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

IV4885 IV5600  Lot codes: 2015090790 2015112390 2016012590 2016030790 2016052390 2016062790 2016080890 2017010290 2017013090 2017031390 2017052290 2015110201 2016010401 2016040401 2016061301 2016071101 2016082201 2017021601 2017041790 2017052290 2016122701 2015092801 2016022201 2017031301 2017062690

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 #162176. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.