Z-2638-2024 Class II Ongoing

Recalled by Argon Medical Devices, Inc — Athens, TX

FDA device recall Z-2638-2024 was initiated by Argon Medical Devices, Inc on June 14, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 155.

Recall Details

Product Type
Devices
Report Date
August 21, 2024
Initiation Date
June 14, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
155

Product Description

L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539

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.

Distribution Pattern

US distribution to the states of: TX, WA, CA, IL

Code Information

UDI-DI: 20886333209938, 00886333209934. Lot: 11563923. Expiration: 2027-03-11