TERUMO(R) Overpressure Safety Valve recall
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Why was TERUMO(R) Overpressure Safety Valve recalled?
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, TL08, TL21, TM28, TP14, UA11, UA18, UA25, UC08, UC22, UD14, UD21, UD28, UE05, UE18, UF09, UG06, UK01, UL12, UM10, UM31, UP05, VA02, VC06, VD06, VE10 (b) RH14, RH21, RK18, RL15, RM01, RM22, RN24, RP01, TA19, TF05, TF27, TG19, TH20, TK24, TL01, TM12, TN09, TP03, UA20, UC15, UD22, UE04, UE18, UF02, UG13, UH11, UK15, UL06, UM10, VA02, VA30, VC27, VE03, VF01 LH130 PRODUCT CORRECTION lot codes or serial number range: TA19 through VD06, distribution date range: 08Apr2015 through 20Jan2017
- Product
- TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 297,222 units
- Distribution
- Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
- Recall date
- December 27, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)