Transvenous Pacing Electrode Tray w/ Bipolar Balloon recall: Sterility Concern
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Why was Transvenous Pacing Electrode Tray w/ Bipolar Balloon recalled?
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)
- Product
- Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 950
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Recall date
- July 22, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)