Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2017 - (Recall #: Z-0256-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

Product Classification:

Class II

Date Initiated: June 27, 2017

Date Posted: December 27, 2017

Recall Number: Z-0256-2018

Event ID: 78546

Reason for Recall:

Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.

Status: Terminated

Product Quantity: 297,222 units

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

Distribution Pattern:

Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan

Voluntary or Mandated:

Voluntary: Firm initiated