AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect
AngioDynamics is recalling 8 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.
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: The recall involves a medical device defect that prevents the intended use of the product (inability to accept the guidewire), representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
AngioDynamics Inc. is recalling 8 units of the NAMIC Convenience Kit Holyoke Hospital Special Procedure Kit (Catalog No. 60080094, UPN Product No. H749600800941). The affected units are from Batch/Lot 4925662 with a Use By date of 2017-02. These kits were distributed nationwide in California, Illinois, Massachusetts, South Carolina, and Texas.
The recall was initiated because the inner lumen of the needles in the affected lot does not meet the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038-inch guidewire as intended, with some inner lumens found to be 0.036 inches. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel before sliding the catheter over the guidewire.
Healthcare facilities and consumers who have these specific kits should stop using them and contact AngioDynamics Inc. for further instructions on return or replacement.
The recalled product
- Product
- NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter o
- Manufacturer
- AngioDynamics Inc.
- Affected units
- 8
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)
- Batch/Lo. 4925662 Use By 2017-02
Distribution
Part of a larger recall action
This product is one of 4 recalled by AngioDynamics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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