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L-CATH PICC S/L Peripherally Inserted Central Catheter… recallZ-2638-2024 · Argon Medical Devices, Inc · initiated Jun 14, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Employee error

What the company is doing

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 [email protected] If you need assistance in returning the units, please contact [email protected]. If you have any questions about this letter, please contact [email protected] or [email protected].

Recall details

Recall number
Z-2638-2024
Status
Open, Classified
Initiated by the company
Jun 14, 2024
Posted by the FDA
Aug 16, 2024
Recalling firm
Argon Medical Devices, Inc
Quantity
155
Product code
LJS
FDA submissions
K230669
Distribution
US distribution to the states of: TX, WA, CA, IL

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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