Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b)...

FDA Recall #Z-1118-2023 — Class II — December 7, 2022

Recall #Z-1118-2023 Date: December 7, 2022 Classification: Class II Status: Ongoing

Product Description

Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595

Reason for Recall

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

630 units

Distribution

Nationwide

Code Information

a) Reorder Number DYNDA2524, GTIN 40193489361415, Lot # 22HME893 b) Reorder Number DT22705A, GTIN 40653160993224, Lot # 22HMC897 c) Reorder Number IV8635D, GTIN 40653160990261, Lot# 22HMH318 d) Reorder Number MNS12595, GTIN 40653160991015, Lot # 22HMD598

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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