—#181060

Product

Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit 20ga x 3", Ref 498411B, Qty: 10/CS

FDA product code: GDY — Gauze/Sponge, Internal, X-Ray Detectable
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K780871
Affected lot / code info: Lot: 11299236

Why it was recalled

Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Argon Medical Devices, Inc. sent Urgent Medical Device Recall letters, dated April 7, 2020 by mail on April 8th to the affected customer/hospital/distributors. The letter states they shipped Arterial Line Kits that include a different suture set than what is normally packaged in the kits the customers order. The kits customers normally order include a straight-cutting needle with a 3-0 silk suture. The kits customers recently received from them include a curved reverse-cutting needle with a 0-silk suture. A list of the affected product numbers is provided in the letter. They immediately corrected the production error that created this situation and reestablished their supply of Arterial Line Kits with the correct suture set. If customers would like to exchange the Arterial Line Kits they received for kits containing the correct suture set, they will gladly exchange these kits at no cost. Conversely, they understand the rise of the recent COVID-19 pandemic put Arterial Line Kits in high demand in the United States. Therefore, they do not require customers to return the affected Arterial Line Kits if they would prefer to use them as-is. To facilitate an exchange of the product received customers can contact Argon Medical Customer Service at 1-800-927-4669 or customer.service@argonmedical.com. If customers would prefer to use the product as-is, no further action is necessary. The letter included a form for customers to acknowledge receipt and account for product inventory and submit for exchange if they wish.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None

Timeline

Recall initiated: 2020-04-08
Terminated: 2022-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.