Device 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
Z-1936-2020
Product summary
- Event
- Event 85488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150
- Official record key
device-enforcement:Z-1936-2020
Official wording
Reason: 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.
Code information: Lot: 11299236
Distribution pattern: US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
Derived failure modes
-
Unknown
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.