—#162164

Product

GENERAL PURPOSE INSTRUMENT TRAY

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 75121 75175 71435 75455 75690 SR245 Lot codes: 2017071990 2016110990 2016040790 2017022090 2016112490 2017010390 2017082390 2015101290 2015111790 2016032290 2016051790 2016053090 2016102490 2017013190 2017032990 2017080290 2015110390 2016010490 2016012090 2016020890 2016041890 2016061390 2016090590 2016110790 2017010990 2017021390 2017032190 2015092190 2015120190 2015121490 2016022590 2016120190 2017010390 2017011090 2015093090 2015112390 2016020390 2016092290 2016091590

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 #162164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.