CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report

Terumo(R) Overpressure Safety Valve recalled

Terumo Cardiovascular Systems is recalling Terumo(R) Overpressure Safety Valve. The recall was initiated on 27 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSAFETY 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

Quantity recalled297,222 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0256-2018
FDA event ID: 78546
Recalling firm: Terumo Cardiovascular Systems, Elkton, MD
Classification: Class II
Status: Terminated
Recall initiated: 27 Jun 2017
FDA classified: 18 Dec 2017
Reported: 27 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Jun 2017	Recall initiated by company
18 Dec 2017	Classified by FDA	+174 days
27 Dec 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Stores named: CVS

Questions about this recall

Is Terumo(R) Overpressure Safety Valve recalled?

Yes. Terumo Cardiovascular Systems recalled Terumo(R) Overpressure Safety Valve on 27 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0256-2018.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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