FDAClass IIJuly 12, 2023

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

Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

Why was Custom medical procedure packs labeled as: a) PELVIC 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 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114

Product
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Recalling firm
DeRoyal Industries Inc
Quantity
3 packs
Distribution
US Nationwide distribution.
Recall date
July 12, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls