Z-0256-2018Class II

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

Name: Z-0256-2018 TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Creator: Terumo Cardiovascular Systems Corporation
Published: 2017-06-27
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2017-06-27 / Terminated

FDA source

Terumo Cardiovascular Systems Corporation began a recall of TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J on 2017-06-27. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0256-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-27
Posted: 2018-06-21
Terminated: 2019-07-16
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
FDA root cause: Process change control
Action: The firm sent a safety alert to its consignees on 07/27/2017 by mail. The notice requested that the consignee test the product prior to using. If the product did not operate, the consignee was asked to return it. Beginning on 12/11/2017 the firm conducted a removal by mail of any remaining product. The customer instructions are as follows: CUSTOMER INSTRUCTIONS Review this Medical Device Recall Notice. Assure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product that is subject to this action. Confirm receipt of this notification by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form . Terumo CVS will issue a Returned Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday- Friday, 8 a.m . - 6 p.m. ET Terumo Safety Alert Fax: 1.410.392.7183 Terumo Safety Alert Email: [email protected]
Quantity in commerce: 297,222 units
Distribution: Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0256-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0256-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-18
Z-0257-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-18

Product code DTL

K820297Class IIWm. Harvey Overpressure Safety ValveC.R. Bard, Inc. / cleared 1982-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)