Introducer Needles Recalled Over Potential Sterile Barrier Packaging Seal Failure
Galt Medical Corporation is recalling Introducer Needles (REF NDL-107-04, lot 24108670) due to a potential open seal in sterile barrier packaging. Distribution included multiple U.S. states and international locations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall involving potential sterile barrier compromise on an invasive medical device with no reported illnesses or injuries. The hazard is theoretical contamination risk from packaging failure, classifying this as a risk-of-harm product without reported injury.
Plain-English summary
Galt Medical Corporation is recalling Introducer Needles (catalog number NDL-107-04, lot 24108670) due to a potential open seal in the sterile barrier packaging. These sterile medical devices are used for the percutaneous introduction of guidewires during medical procedures.
The affected lot was distributed worldwide and in U.S. states including Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah. International distribution included Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom.
A potential open seal in the sterile barrier packaging could allow the device to become contaminated. This poses a risk if a contaminated needle is used during a patient procedure.
Affected healthcare facilities should verify whether they have received product from lot 24108670 and follow Galt Medical Corporation's instructions regarding this recall.
The recalled product
- Product
- Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
- Manufacturer
- Galt Medical Corporation
- Hazard
- packaging-seal-failure
- sterility-compromise
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670
Distribution
Distributed nationwide across the United States.
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