Reported Dec 27, 2017 · Terminated

Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US…

Terumo Cardiovascular Systems Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Terumo Cardiovascular Systems Corporation · 125 Blue Ball Rd · Elkton, MD · 21921-5315

Is this the product you have?

  • Custom surgical kits containing TERUMO(R) Overpressure Safety Valve
  • REF(a)
  • LH130 and (b) LH130J Catalog numbersUS
  • distribution

    144 of 144 codes

    • 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
    • 75453
    • 75453-01
    • 75999
    • 75451-01
    • 72481-01
    • 75197
    • 73968
    • 75416
    • 73648
    • 71519-02
    • 71801-01
    • 72846
    • 74163-02
    • 74178-03
    • 74986
    • 75607
    • 74162-01
    • 74163-03
    • 73454-01
    • 71296-01
    • 74924
    • 73344-04
    • 73500-04
    • 74924-01
    • 73143-02
    • 76393
    • 74248-01
    • 73820-01
Lot codes and dates
  • SAFETY ALERT Lot CodesUS
  • DistributionCatalog Number Lot Code

    1,122 of 1,122 codes

    • 74369
    • TH20
    • 74369
    • TH20
    • 74369
    • TH27
    • 74369
    • TH27
    • 74369
    • TK10
    • 74369
    • TL08
    • 74369
    • TL08
    • 74369
    • TL21
    • 74369
    • TL21
    • 74369
    • TM05
    • 74369
    • TM05
    • 74369
    • TM19
    • 74369
    • TM19
    • 74369
    • TM26
    • 74369
    • TM26
    • 74369
    • TM26
    • 74369
    • TN16
    • 74369
    • TN16
    • 74369
    • TP07
    • 74369
    • TP07
    • 74369
    • TP14
    • 74369
    • TP14
    • 74369
    • TP14
    • 74369
    • UA25
    • 74369
    • UA25
    • 74369
    • UA25
    • 74369
    • UA25
    • 74369
    • UC01
    • 74369
    • UC01
    • 74369
    • UC01
Amount recalled
214146 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 16, 2019 · Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.