| Date Initiated by Firm | May 26, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on September 14, 2004 |
| Recall Number | Z-1003-04 |
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| Recall Event ID |
29196 |
| 510(K)Number | K874393 |
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| Product Classification |
Tube, Feeding - Product Code FPD
|
| Product | Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single Use Only, Rx Only***COOK Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 |
|---|
| Code Information |
Reorder/Catalog Number: NJFT-1-ML, Lot #1803299, Expiration Date: 09-2008 |
Recalling Firm/
Manufacturer |
Wilson-Cook Medical Inc
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
|
| For Additional Information Contact | Jessica Hughes
800-245-4707 |
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Manufacturer Reason
for Recall | The nasal transfer tube may be missing from the package of the affected lot. |
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FDA Determined
Cause 2 | Other |
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| Action | For the Domestic account, a recall letter was hand delivered by a Wilson-Cook representative on 5/26/2004. A letter was delivered via fax to International Distributors on 5/26/2004. |
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| Quantity in Commerce | 20 units |
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| Distribution | NC, Ireland & Poland |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = FPD
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