Medical Device Recall #29389 | Medicaldevicehub

CFRES ID:	90514
Device Name:	N/A
Product RES Number:	Z-1742-2010
Event Date Initiated:	2010-03-29
Event Date Posted:	2010-06-02
Event Date Created:	N/A
Event Date Terminated:	2010-07-29
Recall Status:	Terminated
Res Event Number:	55234
Product Code:	KGC
K Numbers:	["K780871"]
PMA Numbers:	N/A
Product Description:	ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
Code Info:	Catalog Number: 498411B, Lot Number: 99736745, Expiration Date: 2012-10.
Recalling Firm:	Argon Medical Devices, Inc
Firm FEI Number:	N/A
Adress 1:	1445 Flat Creek Rd
Adress 2:	N/A
City:	Athens
State:	TX
Postal Code:	75751
Additional Contact Info:	Andrea Wieczor 903-677-9375
Reason for Recall:	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Root Cause Description:	Package design/selection
Other Submission Description:	N/A
Action:	Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm. For further information, contact Argon Medical Devices at 1-903-677-9375.
Product Quantity:	121 kits
Distribution Pattern:	Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-06-02
Device Class:	N/A
Open FDA:	{"k_number"=>["K904801", "K910584", "K900884", "K902121", "K901791", "K860441", "K894653", "K781333", "K193612", "K170323", "K901501", "K120587", "K904779", "K903036", "K901795", "K073718", "K093312", "K080253", "K183057", "K910492", "K191844", "K903086", "K980145", "K182832"], "registration_number"=>["2527072", "9681260", "1526012", "3005099803", "1820334", "3009888344", "1000121056", "3010605677", "1643817", "1644312", "3017871347", "1625425", "3006082230", "3012494290", "1828132", "1048014", "3007289408", "3015177732", "3003915875", "3011270181", "1000393132", "3008717566", "1018233", "1417592", "2528981", "3008848274", "3005636544", "9611594", "3006260740"], "fei_number"=>["2527072", "1526012", "3005099803", "1820334", "3009888344", "1000117748", "3002806436", "1000121056", "3010605677", "1643817", "3017871347", "1625425", "3006082230", "3012494290", "1828132", "1048014", "3007289408", "3015177732", "3002806565", "3003915875", "3011270181", "1000393132", "3008717566", "1018233", "1417592", "2528981", "3008848274", "3005636544", "3006260740"], "device_name"=>"Tube, Gastro-Enterostomy", "medical_specialty_description"=>"Gastroenterology, Urology", "regulation_number"=>"876.5980", "device_class"=>"2"}

CFRES ID:

90514

Device Name:

N/A

Product RES Number:

Z-1742-2010

Event Date Initiated:

2010-03-29

Event Date Posted:

2010-06-02

Event Date Created:

N/A

Event Date Terminated:

2010-07-29

Recall Status:

Terminated

Res Event Number:

55234

Product Code:

KGC

K Numbers:

["K780871"]

PMA Numbers:

N/A

Product Description:

ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

Code Info:

Catalog Number: 498411B, Lot Number: 99736745, Expiration Date: 2012-10.

Recalling Firm:

Argon Medical Devices, Inc

Firm FEI Number:

N/A

Adress 1:

1445 Flat Creek Rd

Adress 2:

N/A

City:

Athens

State:

TX

Postal Code:

75751

Additional Contact Info:

Andrea Wieczor 903-677-9375

Reason for Recall:

There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

Root Cause Description:

Package design/selection

Other Submission Description:

N/A

Action:

Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm. For further information, contact Argon Medical Devices at 1-903-677-9375.

Product Quantity:

121 kits

Distribution Pattern:

Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.

Medical Speciality Description:

N/A

Regulation Number:

N/A

Event Date Posted:

2010-06-02

Device Class:

N/A

Open FDA:

{"k_number"=>["K904801", "K910584", "K900884", "K902121", "K901791", "K860441", "K894653", "K781333", "K193612", "K170323", "K901501", "K120587", "K904779", "K903036", "K901795", "K073718", "K093312", "K080253", "K183057", "K910492", "K191844", "K903086", "K980145", "K182832"], "registration_number"=>["2527072", "9681260", "1526012", "3005099803", "1820334", "3009888344", "1000121056", "3010605677", "1643817", "1644312", "3017871347", "1625425", "3006082230", "3012494290", "1828132", "1048014", "3007289408", "3015177732", "3003915875", "3011270181", "1000393132", "3008717566", "1018233", "1417592", "2528981", "3008848274", "3005636544", "9611594", "3006260740"], "fei_number"=>["2527072", "1526012", "3005099803", "1820334", "3009888344", "1000117748", "3002806436", "1000121056", "3010605677", "1643817", "3017871347", "1625425", "3006082230", "3012494290", "1828132", "1048014", "3007289408", "3015177732", "3002806565", "3003915875", "3011270181", "1000393132", "3008717566", "1018233", "1417592", "2528981", "3008848274", "3005636544", "3006260740"], "device_name"=>"Tube, Gastro-Enterostomy", "medical_specialty_description"=>"Gastroenterology, Urology", "regulation_number"=>"876.5980", "device_class"=>"2"}

Detailed Result for Z-1742-2010