Melrose Wakefield Hospital recall: Sterility Concern
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate…
Why was Melrose Wakefield Hospital recalled?
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
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?
Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877
- Product
- Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 432 devices
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.
- Recall date
- October 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)