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Devices
Device Recall Overpressure Safety Valve
Model / Serial
SAFETY ALERT Lot Codes: (a) RH14, RK11, RK20, RL02, RM06, RM20, RN10, RP08, TD16, TE13, TE27, TF14, TF21, TG04, TG11, TG17, TH06, TH16, TK10, TK24, TL08, TL21, TM28, TP14, UA11, UA18, UA25, UC08, UC22, UD14, UD21, UD28, UE05, UE18, UF09, UG06, UK01, UL12, UM10, UM31, UP05, VA02, VC06, VD06, VE10 (b) RH14, RH21, RK18, RL15, RM01, RM22, RN24, RP01, TA19, TF05, TF27, TG19, TH20, TK24, TL01, TM12, TN09, TP03, UA20, UC15, UD22, UE04, UE18, UF02, UG13, UH11, UK15, UL06, UM10, VA02, VA30, VC27, VE03, VF01 LH130 PRODUCT CORRECTION lot codes or serial number range: TA19 through VD06, distribution date range: 08Apr2015 through 20Jan2017
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
Product Description
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Manufacturer
Terumo Cardiovascular Systems Corporation
1 Event
Recall of Device Recall Overpressure Safety Valve
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Manufacturer
Terumo Cardiovascular Systems Corporation
Manufacturer Address
Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA
One device with a similar name
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Device Recall Overpressure Safety Valve
Model / Serial
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
Product Description
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J || Catalog numbers: || US distribution: || LH130 || 74369 || 71156 || 71551-02 || 71413 || 71692 || 74102 || 75490 || 74432-01 || 75477 || 75478 || 75104-02 || 75104-03 || 75477-01 || 75037 || 75973 || 75308-01 || 75688 || 70571-06 || 75114-01 || 72755 || 73306 || 71180-01 || 73307 || 75163 || 75164 || 75787 || 75163-01 || 73055-02 || 75450 || 75451 || 75452 || 75453 || 75453-01 || 75999 || 75451-01 || 72481-01 || 75197 || 73968 || 75416 || 73648 || 71519-02 || 71801-01 || 72846 || 74163-02 || 74178-03 || 74986 || 75607 || 74162-01 || 74163-03 || 73454-01 || 71296-01 || 74924 || 73344-04 || 73500-04 || 74924-01 || 73143-02 || 76393 || 74248-01 || 73820-01 || 75261 || 75594 || 74022-01 || 66001-01 || 66004-01 || 74916 || 72736-02 || B72736-02 || 70815 || 70815-01 || 70815-02 || 74356-02 || 73208-03 || 73001-02 || 73957-01 || 74460-01 || 70089-06 || 75168 || 75171 || 75240 || 74382-01 || 66467 || 70089-07 || 74965-03 || 75168-01 || 75240-01 || 66467-01 || 70089-08 || 73177 || 76006 || 73177-01 || 76038 || 75252-01 || 76316 || 75805-02 || 73346 || 76414 || 75790 || 75678 || 62007-01 || 66229 || 75075 || 62007-02 || 65382 || 75788 || 75788-01 || 70533-10 || 75936 || 75936-01 || 63123 || 72241 || 70148-02 || 70730 || 70772 || 74732 || 75090 || 75090-01 || 75090-02 || 75089-01 || 73468 || 74430 || 74921-02 || 75881 || 64523-02 || 64619-02 || 64522-03 || 64521-02 || 65560-03 || 64912-04 || 65560-04 || 71064 || 65570 || 71062-01 || 71061-02 || 71060-01 || 71962-04 || 71965-04 || 75948 || 71962-05 || 74401-01 || 74400-01 || 74399-02 || 75944 || 759
Manufacturer
Terumo Cardiovascular Systems Corporation
Language
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