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Recall Observatory FDA recall evidence

Device product

Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-1220-2014

March 03, 2014

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 67598
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1220-2014

Official wording

Reason: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

Code information: Catalog Number 4935

Distribution pattern: Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.