| | Class 2 Device Recall Portex |  |
| Date Initiated by Firm | November 17, 2005 |
|---|
| Date Posted | November 30, 2005 |
|---|
| Recall Status1 |
Terminated 3 on May 08, 2012 |
| Recall Number | Z-0246-06 |
|---|
| Recall Event ID |
34046 |
| Product Classification |
Anesthesia Conduction Kit - Product Code CAZ
|
| Product | 4950-17 Portex Epidural Mini-pack |
|---|
| Code Information |
Lot Numbes: 101146, 101452, 105024, 107076, 109224, 111199, K110058, K121072, K124485, K128818, K132630, K141613, K143220, K147085, K151519, K163451, K180107, K189821, K211507, K223552, K527934, K541698, K558498, K598204, K632932, K638749, K642968, K656458, K699000 |
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. 2457 |
|---|
Manufacturer Reason
for Recall | Tray may contain holes compromising the sterility of the device |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
|
|---|
| Distribution | Nationwide |
|---|
| 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.
|
|
|
|
