—#208924

Product

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

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K230669
Affected lot / code info: UDI-DI: 20886333209938, 00886333209934. Lot: 11563923. Expiration: 2027-03-11

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

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

Timeline

Recall initiated: 2024-06-14
Posted by FDA: 2024-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208924. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.