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Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM...

FDA Recall #Z-1120-2023 — Class II — December 7, 2022

Recall #Z-1120-2023 Date: December 7, 2022 Classification: Class II Status: Ongoing

Product Description

Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063

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

981 units

Distribution

Nationwide

Code Information

a) Reorder number DYNDC2733, GTIN 40888277783974, Lot # 22HMG957; b) Reorder number SUT14640, GTIN 40653160184158, Lot # 22HMG490

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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