Reported Dec 27, 2017 · Terminated
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
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?
- TERUMO(R) Overpressure Safety Valve
- REF(a) LH130 (b) LH130J
- Lot codes and dates
- SAFETY ALERT Lot Codes
78 of 78 codes
(a) RH14RK11RK20RL02RM06RM20RN10RP08TD16TE13TE27TF14TF21TG04TG11TG17TH06TH16TK10TK24TL08TL21TM28TP14UA11UA18UA25UC08UC22UD14UD21UD28UE05UE18UF09UG06UK01UL12UM10UM31UP05VA02VC06VD06VE10 (b) RH14RH21RK18RL15RM01RM22RN24RP01TA19TF05TF27TG19TH20TK24TL01TM12
- lot codes or serial number rangeTA19 through VD06
- distribution date range08Apr2015 through 20Jan2017
- SAFETY ALERT Lot Codes
- Amount recalled
- 297,222 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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