Medical Device Recall #29387 | Medicaldevicehub

CFRES ID:	91603
Device Name:	N/A
Product RES Number:	Z-1762-2010
Event Date Initiated:	2010-01-08
Event Date Posted:	2010-06-04
Event Date Created:	N/A
Event Date Terminated:	2012-07-25
Recall Status:	Terminated
Res Event Number:	55701
Product Code:	MSD
K Numbers:	N/A
PMA Numbers:	N/A
Product Description:	DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
Code Info:	Lots 978909, 980646, 981113, C68432, C68433, C68434, 981843
Recalling Firm:	Angiodynamics, Inc.
Firm FEI Number:	N/A
Adress 1:	603 Queensbury Avenue
Adress 2:	N/A
City:	Queensbury
State:	NY
Postal Code:	12804
Additional Contact Info:	S. Michael Sharp, PhD, FRAPS 518-798-1215 Ext. 1123
Reason for Recall:	The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test.
Root Cause Description:	Other
Other Submission Description:	N/A
Action:	Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
Product Quantity:	675
Distribution Pattern:	Nationwide and St. Thomas, VI
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-06-04
Device Class:	N/A
Open FDA:	{"k_number"=>["K070572", "K203575", "K022662", "K040509", "K981125", "K100169", "K202150", "K071422", "K002902", "K041914", "K030983", "K140492", "K140884", "K032712", "K041006", "K130192", "K022905", "K161026", "K102043", "K091506", "K981365", "K010306", "K073092", "K030020", "K200627", "K051584", "K060972", "K090148", "K062901", "K010567", "K022678", "K211410", "K123196", "K051748", "K110936", "K113487", "K131260", "K111900", "K141363", "K051280", "K972207", "K080400", "K982326", "K092205", "K042672", "K020465", "K090101", "K982333", "K040736", "K053589", "K111372", "K040328", "K012562", "K203767", "K013160", "K182443", "K030502", "K020315", "K131814", "K021759", "K021212", "K111651", "K033676", "K010399", "K210461", "K102238", "K091760", "K063431", "K090528", "K123943", "K063441", "K003207", "K011916", "K020936", "K072499", "K171618", "K130889", "K040402", "K042858", "K071202", "K040992", "K040260", "K994105", "K971925", "K143567", "K032061", "K151967", "K171571", "K040318", "K043292", "K121933", "K012365", "K033294", "K121848", "K040492", "K030277", "K111117", "K111817", "K041559", "K002901", "K190527", "K023023", "K133796", "K022000", "K130851", "K060155", "K062671", "K060288", "K981994", "K101843", "K173667", "K092597", "K001633", "K073093", "K040078", "K202176", "K023847", "K173805", "K042016", "K040666", "K141051", "K012948", "K043272"], "registration_number"=>["1833566", "3007544634", "2527072", "3008110587", "1423537", "1721676", "3011534620", "3004111573", "1722746", "1820334", "1319639", "9680794", "3011137372", "3009211636", "2020394", "2244478", "1000523114", "1644312", "1220477", "1625425", "3006082230", "3010882065", "3017892510", "1721504", "1061124", "1048014", "3015409271", "2246552", "3006950086", "3003915875", "3008998256", "3010425778", "1018233", "3002807314", "1282497", "2030624", "1724474", "2528981", "3015859709", "2518433", "3004134316", "9611665", "9617592", "3010041511", "2518902", "1319211", "3005987240", "3006260740"], "fei_number"=>["3007544634", "3000206435", "2527072", "3008110587", "1721676", "3003094851", "3004111573", "3011534620", "1820334", "1000512168", "1000138054", "3009211636", "1000117748", "3002807095", "3005747797", "2020394", "1000523114", "1220477", "1625425", "3006082230", "3017892510", "1721504", "3001236905", "1048014", "3002468371", "3015409271", "2246552", "3006950086", "3003915875", "3003737899", "3008998256", "3010425778", "1018233", "1000136269", "1000115408", "3002807314", "1282497", "1000306216", "3006097687", "2528981", "3015859709", "2518433", "3004134316", "3010041511", "2518902", "1319211", "3005987240", "3006260740"], "device_name"=>"Catheter, Hemodialysis, Implanted", "medical_specialty_description"=>"Gastroenterology, Urology", "regulation_number"=>"876.5540", "device_class"=>"2"}

CFRES ID:

91603

Device Name:

N/A

Product RES Number:

Z-1762-2010

Event Date Initiated:

2010-01-08

Event Date Posted:

2010-06-04

Event Date Created:

N/A

Event Date Terminated:

2012-07-25

Recall Status:

Terminated

Res Event Number:

55701

Product Code:

MSD

K Numbers:

N/A

PMA Numbers:

N/A

Product Description:

DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

Code Info:

Lots 978909, 980646, 981113, C68432, C68433, C68434, 981843

Recalling Firm:

Angiodynamics, Inc.

Firm FEI Number:

N/A

Adress 1:

603 Queensbury Avenue

Adress 2:

N/A

City:

Queensbury

State:

NY

Postal Code:

12804

Additional Contact Info:

S. Michael Sharp, PhD, FRAPS 518-798-1215 Ext. 1123

Reason for Recall:

The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test.

Root Cause Description:

Other

Other Submission Description:

N/A

Action:

Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.

Product Quantity:

675

Distribution Pattern:

Nationwide and St. Thomas, VI

Medical Speciality Description:

N/A

Regulation Number:

N/A

Event Date Posted:

2010-06-04

Device Class:

N/A

Open FDA:

{"k_number"=>["K070572", "K203575", "K022662", "K040509", "K981125", "K100169", "K202150", "K071422", "K002902", "K041914", "K030983", "K140492", "K140884", "K032712", "K041006", "K130192", "K022905", "K161026", "K102043", "K091506", "K981365", "K010306", "K073092", "K030020", "K200627", "K051584", "K060972", "K090148", "K062901", "K010567", "K022678", "K211410", "K123196", "K051748", "K110936", "K113487", "K131260", "K111900", "K141363", "K051280", "K972207", "K080400", "K982326", "K092205", "K042672", "K020465", "K090101", "K982333", "K040736", "K053589", "K111372", "K040328", "K012562", "K203767", "K013160", "K182443", "K030502", "K020315", "K131814", "K021759", "K021212", "K111651", "K033676", "K010399", "K210461", "K102238", "K091760", "K063431", "K090528", "K123943", "K063441", "K003207", "K011916", "K020936", "K072499", "K171618", "K130889", "K040402", "K042858", "K071202", "K040992", "K040260", "K994105", "K971925", "K143567", "K032061", "K151967", "K171571", "K040318", "K043292", "K121933", "K012365", "K033294", "K121848", "K040492", "K030277", "K111117", "K111817", "K041559", "K002901", "K190527", "K023023", "K133796", "K022000", "K130851", "K060155", "K062671", "K060288", "K981994", "K101843", "K173667", "K092597", "K001633", "K073093", "K040078", "K202176", "K023847", "K173805", "K042016", "K040666", "K141051", "K012948", "K043272"], "registration_number"=>["1833566", "3007544634", "2527072", "3008110587", "1423537", "1721676", "3011534620", "3004111573", "1722746", "1820334", "1319639", "9680794", "3011137372", "3009211636", "2020394", "2244478", "1000523114", "1644312", "1220477", "1625425", "3006082230", "3010882065", "3017892510", "1721504", "1061124", "1048014", "3015409271", "2246552", "3006950086", "3003915875", "3008998256", "3010425778", "1018233", "3002807314", "1282497", "2030624", "1724474", "2528981", "3015859709", "2518433", "3004134316", "9611665", "9617592", "3010041511", "2518902", "1319211", "3005987240", "3006260740"], "fei_number"=>["3007544634", "3000206435", "2527072", "3008110587", "1721676", "3003094851", "3004111573", "3011534620", "1820334", "1000512168", "1000138054", "3009211636", "1000117748", "3002807095", "3005747797", "2020394", "1000523114", "1220477", "1625425", "3006082230", "3017892510", "1721504", "3001236905", "1048014", "3002468371", "3015409271", "2246552", "3006950086", "3003915875", "3003737899", "3008998256", "3010425778", "1018233", "1000136269", "1000115408", "3002807314", "1282497", "1000306216", "3006097687", "2528981", "3015859709", "2518433", "3004134316", "3010041511", "2518902", "1319211", "3005987240", "3006260740"], "device_name"=>"Catheter, Hemodialysis, Implanted", "medical_specialty_description"=>"Gastroenterology, Urology", "regulation_number"=>"876.5540", "device_class"=>"2"}

Detailed Result for Z-1762-2010