Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2012 - (Recall #: Z-0071-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.

Product Classification:

Class II

Date Initiated: October 2, 2009

Date Posted: October 24, 2012

Recall Number: Z-0071-2013

Event ID: 63225

Reason for Recall:

Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a

Status: Terminated

Product Quantity: 33 units

Code Information:

No lot/serial number; Catalog number: PN 816280

Distribution Pattern:

Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.

Voluntary or Mandated:

Voluntary: Firm initiated