| | Class 2 Device Recall |  |
| Date Initiated by Firm | March 25, 2003 |
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| Date Posted | April 22, 2003 |
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| Recall Status1 |
Terminated 3 on September 09, 2003 |
| Recall Number | Z-0773-03 |
|---|
| Recall Event ID |
25830 |
| Product | ISOLATION GOWN PACK |
|---|
| Code Information |
Catalog Number CPA-1431 Lot Numbers 000000848, 000000849, 000002055, 000002828, 000002829, 000004637, 000004638 |
Recalling Firm/
Manufacturer |
Windstone Medical, Inc.
1602 4th Ave North
Billings MT 59101
|
| For Additional Information Contact | Troy Berquist
406-259-6387 |
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Manufacturer Reason
for Recall | Product contains latex, but not labeled as containing latex. |
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FDA Determined
Cause 2 | Other |
|---|
| Action | On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm. |
|---|
| Quantity in Commerce | 90 |
|---|
| Distribution | The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA. |
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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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