Medical Device Recall #29394 | Medicaldevicehub

CFRES ID:	92696
Device Name:	N/A
Product RES Number:	Z-2190-2010
Event Date Initiated:	2010-07-01
Event Date Posted:	2010-08-09
Event Date Created:	N/A
Event Date Terminated:	2010-08-20
Recall Status:	Terminated
Res Event Number:	56115
Product Code:	DXE
K Numbers:	["K060092", "K073519"]
PMA Numbers:	N/A
Product Description:	Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
Code Info:	Lot numbers FQT09K07A through FQT10F09A.
Recalling Firm:	Spectranetics Corporation
Firm FEI Number:	N/A
Adress 1:	96 Talamine Ct
Adress 2:	N/A
City:	Colorado Springs
State:	CO
Postal Code:	80907-5159
Additional Contact Info:	719-447-2539
Reason for Recall:	Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
Root Cause Description:	Process control
Other Submission Description:	N/A
Action:	Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.
Product Quantity:	5080 units (1778 US, 3302 Non-US)
Distribution Pattern:	Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela.
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-08-09
Device Class:	N/A
Open FDA:	{"k_number"=>["K761031", "K850015", "K780762", "K961716", "K812640", "K820646", "K974335", "K163353", "K022145", "K893680", "K840198", "K973477", "K972572", "K770714", "K163031", "K971314", "K832023", "K193379", "K920823", "K152335", "K961883", "K970762", "K982141", "K992368", "K213771", "K955125", "K901502", "K864330", "K992934", "K901625", "K972511", "K901627", "K954760", "K897184", "K770569", "K011783", "K935405", "K905139", "K100840", "K914880", "K950586", "K972623", "K970657", "K973465", "K894681", "K864007", "K891021", "K790838", "K202049", "K902327", "K832044", "K892410", "K081573", "K900311", "K910372", "K881455", "K883852", "K872485", "K002627", "K780244", "K920871", "K992933", "K100842", "K961992", "K020634", "K801650", "K864062", "K992940", "K853625"], "registration_number"=>["2022435", "2183930", "2032521", "2027111", "3005221616", "1721676", "8043983", "1820334", "1319639", "3004832480", "3011137372", "2015691", "9680794", "1000121056", "3005704822", "2134265", "2030598", "2183744", "1220948", "2029386", "1220477", "1220452", "1048735", "1721504", "1061124", "1225687", "3012102437", "3013443288", "3010034260", "9617465", "2183870", "1000393132", "3009051888", "3008496528", "1721686", "2648045", "3013666218", "2011171", "2030624", "1724474", "3015859709", "2518433", "2024311", "3010041511", "2522007"], "fei_number"=>["2022435", "3000206435", "2027111", "3005221616", "1721676", "3003094851", "1820334", "1000512168", "1000138054", "3004832480", "3002095335", "2015691", "1000121056", "3005704822", "3005747797", "3003769549", "2183744", "1220948", "1220477", "1220452", "1048735", "1000116127", "3001451463", "1721504", "3012102437", "3013443288", "1000518731", "3010034260", "3016261803", "3003574398", "3003737899", "2183870", "1000393132", "1000306647", "3009051888", "3008496528", "1721686", "2648045", "3013666218", "2011171", "3015859709", "2518433", "2024311", "3010041511", "2522007"], "device_name"=>"Catheter, Embolectomy", "medical_specialty_description"=>"Cardiovascular", "regulation_number"=>"870.5150", "device_class"=>"2"}

CFRES ID:

92696

Device Name:

N/A

Product RES Number:

Z-2190-2010

Event Date Initiated:

2010-07-01

Event Date Posted:

2010-08-09

Event Date Created:

N/A

Event Date Terminated:

2010-08-20

Recall Status:

Terminated

Res Event Number:

56115

Product Code:

DXE

K Numbers:

["K060092", "K073519"]

PMA Numbers:

N/A

Product Description:

Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.

Code Info:

Lot numbers FQT09K07A through FQT10F09A.

Recalling Firm:

Spectranetics Corporation

Firm FEI Number:

N/A

Adress 1:

96 Talamine Ct

Adress 2:

N/A

City:

Colorado Springs

State:

CO

Postal Code:

80907-5159

Additional Contact Info:

719-447-2539

Reason for Recall:

Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.

Root Cause Description:

Process control

Other Submission Description:

N/A

Action:

Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.

Product Quantity:

5080 units (1778 US, 3302 Non-US)

Distribution Pattern:

Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela.

Medical Speciality Description:

N/A

Regulation Number:

N/A

Event Date Posted:

2010-08-09

Device Class:

N/A

Open FDA:

{"k_number"=>["K761031", "K850015", "K780762", "K961716", "K812640", "K820646", "K974335", "K163353", "K022145", "K893680", "K840198", "K973477", "K972572", "K770714", "K163031", "K971314", "K832023", "K193379", "K920823", "K152335", "K961883", "K970762", "K982141", "K992368", "K213771", "K955125", "K901502", "K864330", "K992934", "K901625", "K972511", "K901627", "K954760", "K897184", "K770569", "K011783", "K935405", "K905139", "K100840", "K914880", "K950586", "K972623", "K970657", "K973465", "K894681", "K864007", "K891021", "K790838", "K202049", "K902327", "K832044", "K892410", "K081573", "K900311", "K910372", "K881455", "K883852", "K872485", "K002627", "K780244", "K920871", "K992933", "K100842", "K961992", "K020634", "K801650", "K864062", "K992940", "K853625"], "registration_number"=>["2022435", "2183930", "2032521", "2027111", "3005221616", "1721676", "8043983", "1820334", "1319639", "3004832480", "3011137372", "2015691", "9680794", "1000121056", "3005704822", "2134265", "2030598", "2183744", "1220948", "2029386", "1220477", "1220452", "1048735", "1721504", "1061124", "1225687", "3012102437", "3013443288", "3010034260", "9617465", "2183870", "1000393132", "3009051888", "3008496528", "1721686", "2648045", "3013666218", "2011171", "2030624", "1724474", "3015859709", "2518433", "2024311", "3010041511", "2522007"], "fei_number"=>["2022435", "3000206435", "2027111", "3005221616", "1721676", "3003094851", "1820334", "1000512168", "1000138054", "3004832480", "3002095335", "2015691", "1000121056", "3005704822", "3005747797", "3003769549", "2183744", "1220948", "1220477", "1220452", "1048735", "1000116127", "3001451463", "1721504", "3012102437", "3013443288", "1000518731", "3010034260", "3016261803", "3003574398", "3003737899", "2183870", "1000393132", "1000306647", "3009051888", "3008496528", "1721686", "2648045", "3013666218", "2011171", "3015859709", "2518433", "2024311", "3010041511", "2522007"], "device_name"=>"Catheter, Embolectomy", "medical_specialty_description"=>"Cardiovascular", "regulation_number"=>"870.5150", "device_class"=>"2"}

Detailed Result for Z-2190-2010