L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA device recall Z-2638-2024 · posted 2024-08-16 · Open, Classified
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
- Action taken
- On 6/14/24,"URGENT PRODUCT RECALL NOTICE"s were emailed to Physicians, Clinicians, or Hospital Administrators describing the product, problem and the following actions to be taken. The customers were instructed to do the following: 1) Immediately discontinue use of the recalled device. 2) Segregate and quarantine the product subject to recall. 3) Return all affected devices to firm at Argon s expense, using RGA# 28348 to the following mailing address: RGA# 28348, Argon Medical Devices, Inc.,1445 Flat Creek Road Athens, TX 75751 USA, Attn: Arbee Cummings. 4) The recall notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred or further distributed. 5) Complete and return the response form via email to arbee.cummings@argonmedical.com If you need assistance in returning the units, please contact arbee.cummings@argonmedical.com. If you have any questions about this letter, please contact Jorge.Garcia@argonmedical.com or Scott.Bishop@argonmedical.com.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- LJS
- Quantity affected
- 155
- Distribution
- US distribution to the states of: TX, WA, CA, IL
- Date initiated
- 2024-06-14
- Date posted
- 2024-08-16
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (K230669) | Argon Medical Devices | 2023-11-30 |