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Recall Observatory FDA recall evidence

Device product

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.

Z-0071-2013

October 02, 2009

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 63225
Status
Terminated
Classification
Class II
Quantity
33 units
Official record key
device-enforcement:Z-0071-2013

Official wording

Reason: 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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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