| Class 2 Device Recall | |
Date Initiated by Firm | March 25, 2003 |
Date Posted | April 22, 2003 |
Recall Status1 |
Terminated 3 on September 09, 2003 |
Recall Number | Z-0764-03 |
Recall Event ID |
25830 |
Product | LAMINECTOMY PACK |
Code Information |
Catalog Number CPA-2390 Lot Numbers 007253617, 007253618, 000000151, 000000426, 000000536, 000001201, 000001517, 000001772, 000001961, 000002108, 000002109, 000002409, 000002588, 000002589, 000002907, 000002908, 000003429, 000003430, 000003738, 000003739, 000004355, 000004356, 000004802, 000004803, 000005460, 000005506, 000005825, 000005786, 000006248, 000006410, 000006532 |
Recalling Firm/ Manufacturer |
Windstone Medical, Inc. 1602 4th Ave North Billings MT 59101
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For Additional Information Contact | Troy Berquist 406-259-6387 |
Manufacturer Reason for Recall | Product has latex free symbol on package, yet contains latex components. |
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 | 709 |
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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