| | Class 2 Device Recall Portex |  |
| Date Initiated by Firm | September 09, 2004 |
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| Date Posted | November 24, 2004 |
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| Recall Status1 |
Terminated 3 on May 08, 2012 |
| Recall Number | Z-0239-05 |
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| Recall Event ID |
29990 |
| 510(K)Number | K851986 |
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| Product Classification |
Stopcock, I.V. Set - Product Code FMG
|
| Product | Portex 4-Way Stopcock
Catalog Number: T1206 |
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| Code Information |
Lot numbers starting with: 0, 1, 911, 912, K1, K50, K52 |
Recalling Firm/
Manufacturer |
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
|
| For Additional Information Contact | Timothy J. Talcott
603-352-3812 Ext. 2667 |
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Manufacturer Reason
for Recall | Sterility of the device is compromised due to packaging defects |
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FDA Determined
Cause 2 | Other |
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| Action | Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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| Distribution | Nationwide |
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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 = FMG
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