Z-0256-2018 Class II Terminated
FDA device recall Z-0256-2018 was initiated by Terumo Cardiovascular Systems Corporation on June 27, 2017 and is designated Class II. Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve. The recall status is terminated (terminated July 16, 2019). Affected quantity: 297,222 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2017
- Initiation Date
- June 27, 2017
- Termination Date
- July 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 297,222 units
Product Description
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Reason for Recall
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Distribution Pattern
Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
Code Information
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