# FDA recall Z-0257-2018

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2017-06-27.

## Product

Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J  Catalog numbers:  US distribution:  LH130                      74369                      71156                      71551-02                   71413                      71692                      74102                      75490                      74432-01                   75477                      75478                      75104-02                   75104-03                   75477-01                   75037                      75973                      75308-01                   75688                      70571-06                   75114-01                   72755                      73306                      71180-01                   73307                      75163                      75164                      75787                      75163-01                   73055-02                   75450                      75451                      75452                      

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0257-2018
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-27
- **Report date:** 2017-12-27
- **Termination date:** 2019-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elkton, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0257-2018

## Citation

> AI Analytics. FDA recall Z-0257-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0257-2018. Source: US FDA. Licensed CC0.

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