| Date Initiated by Firm | September 18, 2004 |
|---|
| Date Posted | November 19, 2004 |
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| Recall Status1 |
Terminated 3 on August 19, 2005 |
| Recall Number | Z-0210-05 |
|---|
| Recall Event ID |
30161 |
| 510(K)Number | K020655 |
|---|
| Product Classification |
Pump, Infusion, Insulin - Product Code LZG
|
| Product | Deltec Cozmo Insulin Pump |
|---|
| Code Information |
Pump Serial Numbers A20721; A20722; A20723; A20724; A20741; A207742 |
| FEI Number |
2183502
|
Recalling Firm/
Manufacturer |
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
|
Manufacturer Reason
for Recall | The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | All customers were contacted and instructed to only use the Beeper alarm function and not the vibrate alarm feature. Patients were instructed to return the affected pump to Smiths Medical MD upon receipt of the replacement pump. |
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| Quantity in Commerce | 6 pumps to patients and 30 pumps in France |
|---|
| Distribution | 371 = Number of Individual Product Manufactured
6 = Number of Product Distributed to Patients
365 = Number of Products Either at Smiths Medical MD or at the Distributor or with a Smiths Medical MD Sales Rep.
|
|---|
| 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 = LZG
|
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