Introducer Needle recall: Sterility Concern
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Why was Introducer Needle recalled?
Due to a potential open seal in the sterile barrier packaging.
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: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670
- Product
- Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
- Recalling firm
- Galt Medical Corporation
- Quantity
- 200 needles
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
- Recall date
- May 14, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)