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Terminated

Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.

FDA Recall Z-0200-06 · Posted 2005-11-26

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDWF
Date Initiated2005-09-12
Date Terminated2006-03-22
Product Quantity2520

Reason for Recall

There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.

Firm Action

Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K771499FLEXIBLE ARTERIAL CANNULAE3M Health Care, Sarns · 1977-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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