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Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHAN...

FDA Recall #Z-1124-2023 — Class II — December 7, 2022

Recall #Z-1124-2023 Date: December 7, 2022 Classification: Class II Status: Ongoing

Product Description

Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,

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

1588 units

Distribution

Nationwide

Code Information

a) Reorder Number DT21400, GTIN 40653160318225 Lot # 22HMH962; b) Reorder Number DT22255, GTIN 40653160328644 Lot # 22HMH427; c) Reorder Number DYNDC1022GB, GTIN 40195327038701 Lot # 22GBY236

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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