Recall Z-2084-2011
Argon Medical Devices, Inc · initiated March 14, 2011
Product
Argon Medical Devices, Catheter Introducer Kit, Argon PCI Kit with Feather Dilator - Pediatric, 4F, Part Number 496308, Lot Number 99767641 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters.
Codes / lots: Lot number 99767641
Reason for recall
Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
FDA-determined cause: Other
Action taken
Argon Medical Devices sent an Urgent Medical Device Recall letter dated March 14, 2011, by certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine and return any product remaining at their facility utilizing the instruction on the 2011 Tray Recall Response Form. Customers were instructed to complete the response form included with the letter and return by fax or email as indicated as soon as possible. Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. For questions regarding this recall call (903) 677-9375.
Details
- Recall number
- Z-2084-2011
- Initiated
- March 14, 2011
- Posted by FDA
- April 27, 2011
- Terminated
- April 24, 2012
- Product code
- FTN – Plastic Surgery And Accessories Kit
- Quantity
- 10 units
- Distribution
- Worldwide Distribution - USA including AL, AZ, CA, CO, DE, GA, HI, IL, IN, LA, MD, MN, ND, NE, NH, NJ, NY, OK, PA, SC, TX, VA, WA, and WI and the countries of Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands
- Recalling firm
- Argon Medical Devices, Inc, Athens, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2083-2011 | Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F, Part Number 496183, Lot…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2085-2011 | Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2086-2011 | Part Number 496311, Lot Number 99768100 Multi-purpose Kit blister tray coupled with…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2087-2011 | Argon Medical Devices Catheter Introducer Kit, One-Piece/Tuohy-Borst Catheter Introducer…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2088-2011 | Argon Medical Devices Arterial Line Kit/1 20ga x 6", Part Number 498100, Lots 99767185…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2089-2011 | Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit 20gax6in, Part…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2090-2011 | Argon Medical Devices, Arterial Line Kit/1 18ga x 6", Part Number 498104, Lot numbers…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2091-2011 | Argon Medical Devices, Arterial Line Kit/1, 20ga x 3", Part Number 498106, Lot numbers…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2092-2011 | Argon Medical Devices Arterial Line Kit/1, 18ga x 3", Part Number 498110, Lot numbers…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2093-2011 | Argon Medical Devices, Arterial Line Kit, 20ga x 3", Part Number 498411B, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2094-2011 | Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2095-2011 | Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit, 20GX3in, Part…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2096-2011 | Argon Medical Devices, Arterial Line Kit, 18ga x 6", Part Number 498443, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2097-2011 | Argon Medical Devices, Catheter Introducer Kit 5F, Part Number 496190A, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2098-2011 | Argon Medical Devices, Arterial Line Kit, Part Number 498410B, 20gax6", Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2099-2011 | Argon Medical Devices Arterial Line Kit, 18ga x 6", Part Number 498412B, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2100-2011 | Argon Medical Devices, Arterial Line Kit 20ga x 3", Part Number 498421B, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |
| Z-2101-2011 | Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number…Packaging for sterile tray has the potential to have a hole which could compromise sterility for the… | 03/14/2011Terminated |