AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect
AngioDynamics is recalling 136 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended 0.038-inch guidewire.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II and involves a medical device defect that prevents the intended use of the product (inability to accept a guidewire), representing a risk of harm where injury has not yet been reported.
Plain-English summary
AngioDynamics Inc. is recalling 136 units of the NAMIC Convenience Kit Self Regional Healthcare PV Leg Pack, Catalog No. 651919311. The affected products include Batch/Lot No. 4921353 (Use By 2018-05) and Batch/Lot No. 4932710 (Use By 2018-06-30). 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 lots 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. In some cases, the inner lumen was found to be 0.036 inches, which is smaller than the required size.
Healthcare facilities and distributors should stop using the affected products and contact AngioDynamics Inc. for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 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…
- Manufacturer
- AngioDynamics Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 136
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/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30
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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