| Date Initiated by Firm | June 01, 2026 |
|---|
| Date Posted | July 10, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2705-2026 |
|---|
| Recall Event ID |
99069 |
| 510(K)Number | K780126 |
|---|
| Product Classification |
Dilator, vessel, for percutaneous catheterization - Product Code DRE
|
| Product | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular |
|---|
| Code Information |
REF/UDI-DI Box:Unit/Lot(Expiration):
497434/20886333214499:00886333214495/11656891(7/19/2027);
497455/20886333214635:00886333214631/11658984 (7/19/2027);
|
| FEI Number |
1625425
|
Recalling Firm/
Manufacturer |
Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
|
| For Additional Information Contact | Scott Bishop
469-430-0546 |
|---|
Manufacturer Reason
for Recall | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
|---|
FDA Determined
Cause 2 | Material/Component Contamination |
|---|
| Action | On 6/1/2026, correction notices were sent to customers who were asked to do the following:
1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice
2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified:
- Place a copy of this notice with the affected product
- Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine.
3) At the point of use, upon opening the kit, discard the affected Lidocaine vials in accordance with your facility's procedures.
4) Obtain Lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure.
5) Complete and return the response form via email Arbee.cummings@argonmedical.com
|
|---|
| Quantity in Commerce | 200 |
|---|
| Distribution | Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = DRE
|
|---|
