—#162175

Product

NEONATAL IV ACCESS SET

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: IV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790

Why it was recalled

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

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 #162175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.