Z-1937-2020Class II
Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 -
Argon Medical Devices, Inc / initiated 2020-04-08 / Terminated
Argon Medical Devices, Inc began a recall of Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1937-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Argon Medical Devices, Inc
- Product
- Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - 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/1 20ga x 3", Qty: 10/CS, CE 2797
- Product code
- GDY Gauze/Sponge, Internal, X-Ray Detectable
- Reason for recall
- 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.
- FDA root cause
- Under Investigation by firm
- Action
- 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 [email protected]. 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.
- Quantity in commerce
- 20
- Distribution
- US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
- Product codes and lots
- Lot: 11301012
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1936-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1937-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1938-2020 | Class II | Terminated | Voluntary: Firm initiated |
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