Reported Dec 28, 2016 · Terminated
ANGIODYNAMICS Percutaneous Introducer Set under the following labels
Angiodynamics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
ANGIODYNAMICS Percutaneous Introducer Set under the following labels
4 of 4 products
| Model / number | Product as published |
|---|---|
H787065970395 | Catalog No. |
06597039 | 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG |
H787065970415 | Catalog No. |
06597041 | Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick |
- Lot codes and dates
- Batch/Lot
1) 50464262) 50223175032458504067250464285063983 & 5081983
- Batch/Lot
- Amount recalled
- 162 boxes
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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