Date Initiated by Firm | May 22, 2007 |
Date Posted | July 10, 2007 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number | Z-0878-2007 |
Recall Event ID |
37996 |
510(K)Number | K063618 |
Product Classification |
Arterial Cannulae - Product Code DWF
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Product | Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571. |
Code Information |
Lot 2120266. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
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For Additional Information Contact | 800-521-2818 |
Manufacturer Reason for Recall | The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line). |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07. |
Quantity in Commerce | 129 |
Distribution | Nationwide. |
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
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