Introducer Needle REF NDL-107-04 Sterile Packaging Recall
Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 due to potential open seals in sterile barrier packaging, which could compromise product sterility.
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: This is an FDA Class II recall involving a sterile medical device with potential for sterile barrier compromise. Although no illnesses or injuries are reported in the source text, the risk-of-harm nature of a compromised sterile barrier on an invasive device (guidewire introducer needle) meets the High threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Galt Medical Corporation is recalling Introducer Needle REF NDL-107-04 (Catalog Number NDL-107-04, UDI-DI: 00841268102729, Lot Number: 24108670) used for percutaneous introduction of guidewires. The recall is due to a potential open seal in the sterile barrier packaging.
A total of 200 needles have been distributed. Distribution includes the United States (states of Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah) and internationally to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom.
Patients and healthcare providers who have received this product should contact Galt Medical Corporation for instructions on product replacement or disposal. The potential for compromised sterility poses a risk if the product was used in clinical procedures.
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
- sterile-barrier-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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