TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

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

The firm sent a safety alert to its consignees on 07/27/2017 by mail. The notice requested that the consignee test the product prior to using. If the product did not operate, the consignee was asked to return it. Beginning on 12/11/2017 the firm conducted a removal by mail of any remaining product. The customer instructions are as follows: CUSTOMER INSTRUCTIONS Review this Medical Device Recall Notice. Assure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product that is subject to this action. Confirm receipt of this notification by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form . Terumo CVS will issue a Returned Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday- Friday, 8 a.m . - 6 p.m. ET Terumo Safety Alert Fax: 1.410.392.7183 Terumo Safety Alert Email: [email protected]