| Date Initiated by Firm | December 07, 2006 |
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| Date Posted | February 27, 2007 |
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| Recall Status1 |
Terminated 3 on December 05, 2007 |
| Recall Number | Z-0544-2007 |
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| Recall Event ID |
37104 |
| 510(K)Number | K930620 |
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| Product Classification |
arterial perfusion cannulae - Product Code DWF
|
| Product | Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351. |
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| Code Information |
Lot 2119905, exp. October 2009. |
Recalling Firm/
Manufacturer |
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
|
| For Additional Information Contact |
800-262-3304 |
|---|
Manufacturer Reason
for Recall | The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4". |
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FDA Determined
Cause 2 | Other |
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| Action | Consignee was notified via telephone on 12/7/06 and returned the product. |
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| Quantity in Commerce | 10 |
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| Distribution | Pennsylvania. |
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| 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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