FDAClass IIApril 13, 2022

Coryell Memorial Hosp Total recall: Sterility Concern

Coryell Memorial Hosp Total, Joint Pack - Surgical Kit

Why was Coryell Memorial Hosp Total recalled?

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

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?

SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822

Product
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Recalling firm
Stradis Medical, LLC dba Stradis Healthcare
Quantity
348 units
Distribution
US Nationwide distribution in the states of IN, TX, and PA.
Recall date
April 13, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls