FDAClass IIJuly 12, 2023

Custom medical procedure packs labeled as: a) STURDI recall: Sterility Concern

Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014

Why was Custom medical procedure packs labeled as: a) STURDI recalled?

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) REF '89-5014, GTIN 50749756217908 (cs), 00749756217903 (unit), , Lot Numbers: 58770294

Product
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
Recalling firm
DeRoyal Industries Inc
Quantity
40 units
Distribution
US Nationwide distribution.
Recall date
July 12, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls