Detailed Result for Z-1742-2010
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"} |