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Class 2 Device Recall Sarns arterial cannula |
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Date Initiated by Firm |
September 12, 2005 |
Date Posted |
November 26, 2005 |
Recall Status1 |
Terminated 3 on March 22, 2006 |
Recall Number |
Z-0200-06 |
Recall Event ID |
33506 |
510(K)Number |
K771499
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Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
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Product |
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. |
Code Information |
Lots 0385384 and 0386969. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
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For Additional Information Contact |
800-262-3304 Ext. 6066
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Manufacturer 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.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05. |
Quantity in Commerce |
2520 |
Distribution |
Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = 3M HEALTH CARE, SARNS
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