Terumo Overpressure Safety Valve Recalled Due to No Flow Reports
Terumo CVS is recalling 297,222 Overpressure Safety Valves worldwide after receiving reports of no flow through the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device failure (no flow) that poses a risk of harm, but the source text does not explicitly report hospitalizations or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation (Terumo CVS) is recalling 297,222 units of the TERUMO(R) Overpressure Safety Valve, reference numbers LH130 and LH130J. The recall is being conducted because the company has received reports of no flow through the over-pressure safety (OPS) Valve.
The affected products were distributed worldwide, including in the US, Canada, Colombia, UK, Belgium, and Japan. Specific lot codes and serial number ranges are listed in the agency's recall documentation for both reference numbers.
Healthcare providers and consumers should stop using the affected valves and contact Terumo CVS for further instructions or replacement units.
The recalled product
- Product
- TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 297,222
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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