Medical Device Recall #29385 | Medicaldevicehub

CFRES ID:	90656
Device Name:	N/A
Product RES Number:	Z-1490-2010
Event Date Initiated:	2010-04-13
Event Date Posted:	2010-05-06
Event Date Created:	N/A
Event Date Terminated:	2012-01-18
Recall Status:	Terminated
Res Event Number:	55354
Product Code:	JOH
K Numbers:	["K962173"]
PMA Numbers:	N/A
Product Description:	Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
Code Info:	Lot Numbers: 0901002066 through 0907002156
Recalling Firm:	Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Firm FEI Number:	N/A
Adress 1:	6135 Gunbarrel Ave
Adress 2:	N/A
City:	Boulder
State:	CO
Postal Code:	80301-3214
Additional Contact Info:	303-305-2382
Reason for Recall:	Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Root Cause Description:	Process design
Other Submission Description:	N/A
Action:	Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm. For further Information, contact Covidien at 1-800-635-5267.
Product Quantity:	924 units
Distribution Pattern:	Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-05-06
Device Class:	N/A
Open FDA:	{"k_number"=>["K043160", "K030787", "K914088", "K142298", "K954749", "K970365", "K072148", "K013728", "K936133", "K931611", "K151404", "K023918", "K972546", "K100995", "K897102", "K180034", "K022212", "K041485", "K041348", "K133528", "K955680", "K122932", "K040014", "K812163", "K980466", "K990905", "K885130", "K921733", "K930895", "K122235", "K093469", "K083641", "K955564", "K972385", "K962175", "K914183", "K150844", "K923156", "K041044", "K925438", "K925020", "K122531", "K962173", "K911080", "K944178", "K182861", "K170720", "K897005", "K972423", "K923878", "K970811", "K894050", "K962714", "K903435", "K760453", "K961449", "K812302", "K910362", "K203362", "K896547", "K081440", "K193077", "K963732", "K903699", "K913270", "K894613", "K924660", "K952700", "K913859", "K133597", "K964056", "K973829", "K914471", "K936224", "K173912", "K031057", "K014102", "K000964", "K072582", "K123699", "K962078", "K922665", "K051416", "K011210", "K954661", "K885129", "K890194", "K971267", "K142296", "K894614", "K896548", "K982128", "K210833", "K172720", "K193133", "K912967", "K960429", "K003315", "K933412", "K897059", "K925288", "K133173", "K944451", "K932016", "K955516", "K924243", "K945513", "K945874"], "registration_number"=>["8030673", "3013561886", "3009039068", "3014054118", "3016678045", "8032044", "9617604", "2032112", "3008258694", "2648727", "3012542015", "3021632375", "1820334", "8010939", "1319639", "8010485", "3011137372", "8020889", "1824231", "3010220595", "3006017180", "3012636179", "3002808022", "3009771213", "3011880624", "3005941719", "3010605677", "3013596043", "3010189764", "1928237", "3008278458", "1526534", "1219795", "3004365956", "3012494290", "1217052", "3008806809", "3012307300", "1058584", "3004551550", "3013421741", "3011987967", "3012421607", "2024841", "3015973929", "9681384", "3011689956", "1219930", "3014656749", "3013557562", "3008132398", "3009220482", "3013718871", "9610520", "3002807314", "1721686", "3010237023", "3013188547", "2011171", "3011237704", "2936999", "3003761012", "3013298431", "1219103", "3015522053", "1219611", "3009887154", "3010041511", "3015453963"], "fei_number"=>["3004213967", "3013561886", "3002558692", "3009039068", "3014054118", "3016678045", "3008258694", "3002806269", "2648727", "3012542015", "3021632375", "1820334", "1000138054", "1824231", "3010220595", "3006017180", "3012636179", "3002808022", "3009771213", "3011880624", "3010605677", "3005747797", "3013596043", "3010189764", "1928237", "3002807111", "3008278458", "1526534", "1219795", "3004365956", "3012494290", "1217052", "3008806809", "3012307300", "2024841", "3004551550", "3013421741", "3011987967", "3012421607", "3015973929", "3002808493", "3003382061", "1000219637", "3011689956", "1219930", "3014656749", "3013557562", "3009220482", "3002807626", "3013718871", "3002807314", "1721686", "3002807091", "3010237023", "1000148701", "3013188547", "2011171", "3003076831", "3011237704", "2936999", "3003361161", "3003761012", "3013298431", "3002808440", "3015522053", "1219611", "3009887154", "3010041511", "3015453963"], "device_name"=>"Tube Tracheostomy And Tube Cuff", "medical_specialty_description"=>"Anesthesiology", "regulation_number"=>"868.5800", "device_class"=>"2"}

CFRES ID:

90656

Device Name:

N/A

Product RES Number:

Z-1490-2010

Event Date Initiated:

2010-04-13

Event Date Posted:

2010-05-06

Event Date Created:

N/A

Event Date Terminated:

2012-01-18

Recall Status:

Terminated

Res Event Number:

55354

Product Code:

JOH

K Numbers:

["K962173"]

PMA Numbers:

N/A

Product Description:

Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

Code Info:

Lot Numbers: 0901002066 through 0907002156

Recalling Firm:

Nellcor Puritan Bennett Inc. (dba Covidien Ltd)

Firm FEI Number:

N/A

Adress 1:

6135 Gunbarrel Ave

Adress 2:

N/A

City:

Boulder

State:

CO

Postal Code:

80301-3214

Additional Contact Info:

303-305-2382

Reason for Recall:

Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

Root Cause Description:

Process design

Other Submission Description:

N/A

Action:

Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm. For further Information, contact Covidien at 1-800-635-5267.

Product Quantity:

924 units

Distribution Pattern:

Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.

Medical Speciality Description:

N/A

Regulation Number:

N/A

Event Date Posted:

2010-05-06

Device Class:

N/A

Open FDA:

{"k_number"=>["K043160", "K030787", "K914088", "K142298", "K954749", "K970365", "K072148", "K013728", "K936133", "K931611", "K151404", "K023918", "K972546", "K100995", "K897102", "K180034", "K022212", "K041485", "K041348", "K133528", "K955680", "K122932", "K040014", "K812163", "K980466", "K990905", "K885130", "K921733", "K930895", "K122235", "K093469", "K083641", "K955564", "K972385", "K962175", "K914183", "K150844", "K923156", "K041044", "K925438", "K925020", "K122531", "K962173", "K911080", "K944178", "K182861", "K170720", "K897005", "K972423", "K923878", "K970811", "K894050", "K962714", "K903435", "K760453", "K961449", "K812302", "K910362", "K203362", "K896547", "K081440", "K193077", "K963732", "K903699", "K913270", "K894613", "K924660", "K952700", "K913859", "K133597", "K964056", "K973829", "K914471", "K936224", "K173912", "K031057", "K014102", "K000964", "K072582", "K123699", "K962078", "K922665", "K051416", "K011210", "K954661", "K885129", "K890194", "K971267", "K142296", "K894614", "K896548", "K982128", "K210833", "K172720", "K193133", "K912967", "K960429", "K003315", "K933412", "K897059", "K925288", "K133173", "K944451", "K932016", "K955516", "K924243", "K945513", "K945874"], "registration_number"=>["8030673", "3013561886", "3009039068", "3014054118", "3016678045", "8032044", "9617604", "2032112", "3008258694", "2648727", "3012542015", "3021632375", "1820334", "8010939", "1319639", "8010485", "3011137372", "8020889", "1824231", "3010220595", "3006017180", "3012636179", "3002808022", "3009771213", "3011880624", "3005941719", "3010605677", "3013596043", "3010189764", "1928237", "3008278458", "1526534", "1219795", "3004365956", "3012494290", "1217052", "3008806809", "3012307300", "1058584", "3004551550", "3013421741", "3011987967", "3012421607", "2024841", "3015973929", "9681384", "3011689956", "1219930", "3014656749", "3013557562", "3008132398", "3009220482", "3013718871", "9610520", "3002807314", "1721686", "3010237023", "3013188547", "2011171", "3011237704", "2936999", "3003761012", "3013298431", "1219103", "3015522053", "1219611", "3009887154", "3010041511", "3015453963"], "fei_number"=>["3004213967", "3013561886", "3002558692", "3009039068", "3014054118", "3016678045", "3008258694", "3002806269", "2648727", "3012542015", "3021632375", "1820334", "1000138054", "1824231", "3010220595", "3006017180", "3012636179", "3002808022", "3009771213", "3011880624", "3010605677", "3005747797", "3013596043", "3010189764", "1928237", "3002807111", "3008278458", "1526534", "1219795", "3004365956", "3012494290", "1217052", "3008806809", "3012307300", "2024841", "3004551550", "3013421741", "3011987967", "3012421607", "3015973929", "3002808493", "3003382061", "1000219637", "3011689956", "1219930", "3014656749", "3013557562", "3009220482", "3002807626", "3013718871", "3002807314", "1721686", "3002807091", "3010237023", "1000148701", "3013188547", "2011171", "3003076831", "3011237704", "2936999", "3003361161", "3003761012", "3013298431", "3002808440", "3015522053", "1219611", "3009887154", "3010041511", "3015453963"], "device_name"=>"Tube Tracheostomy And Tube Cuff", "medical_specialty_description"=>"Anesthesiology", "regulation_number"=>"868.5800", "device_class"=>"2"}

Detailed Result for Z-1490-2010