Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
FDA Recall #Z-1111-2023 — Class II — December 7, 2022
Product Description
Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
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
units
Distribution
Nationwide
Code Information
GTIN 10888277589490, Lot # 22DBN972
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.