FDAClass IIAugust 24, 2022

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order recall: Labeling Error

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708

Why was Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order recalled?

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

UDI-DI Number: 50649111317590 Case 10649111317590 Kit Lot Numbers: 600001 600002

Product
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Recalling firm
Trinity Sterile, Inc.
Quantity
5 cases (125 eaches )
Distribution
US Nationwide distribution in the states of FL, PA.
Recall date
August 24, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls