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
LH130743697115671551-027141371692741027549074432-01754777547875104-0275104-0375477-01750377597375308-017568870571-0675114-01727557330671180-017330775163751647578775163-0173055-027545075451754527545375453-017599975451-0172481-017519773968754167364871519-0271801-017284674163-0274178-03749867560774162-0174163-0373454-0171296-017492473344-0473500-0474924-0173143-027639374248-0173820-01
- Lot codes and dates
- SAFETY ALERT Lot CodesUS
- DistributionCatalog Number Lot Code
1,122 of 1,122 codes
74369TH2074369TH2074369TH2774369TH2774369TK1074369TL0874369TL0874369TL2174369TL2174369TM0574369TM0574369TM1974369TM1974369TM2674369TM2674369TM2674369TN1674369TN1674369TP0774369TP0774369TP1474369TP1474369TP1474369UA2574369UA2574369UA2574369UA2574369UC0174369UC0174369UC01
- 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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