FDA Enforcement
Class II
Ongoing
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Recall: Z-2638-2024
·
Reported August 21, 2024
Enforcement
- Recall Number
- Z-2638-2024
- Event ID
- 94951
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Argon Medical Devices, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 21, 2024
- Initiation Date
- June 14, 2024
- Classification Date
- August 15, 2024
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002, United States
Description
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Reason
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.
Code Info
UDI-DI: 20886333209938, 00886333209934. Lot: 11563923. Expiration: 2027-03-11
Distribution
US distribution to the states of: TX, WA, CA, IL
Quantity
155