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.
Enforcement
- Recall Number
- Z-0071-2013
- Event ID
- 63225
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- October 24, 2012
- Initiation Date
- October 2, 2009
- Classification Date
- October 16, 2012
- Termination Date
- January 29, 2013
- Address
- 6200 Jackson Road, N/A, Ann Arbor, MI, 48103-9586, United States
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.
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
No lot/serial number; Catalog number: PN 816280
Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.
33 units