Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOU...
FDA Recall #Z-1122-2023 — Class II — December 7, 2022
Product Description
Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
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
1280 units
Distribution
Nationwide
Code Information
Reorder Number DYNJSHOULDER, GTIN 10080196597383, Lot # 22DBN321
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated