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Class 2 Device Recall |
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Date Initiated by Firm |
March 25, 2003 |
Date Posted |
April 22, 2003 |
Recall Status1 |
Terminated 3 on September 09, 2003 |
Recall Number |
Z-0753-03 |
Recall Event ID |
25830 |
510(K)Number |
K902475 K923233 K923231
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Product |
Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc.
All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label.
MAJOR PACK |
Code Information |
Catalog number 002117-000 Lot numbers 000006595, 000006895 |
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
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Manufacturer Reason for Recall |
Product has latex free symbol on package, yet contains latex components.
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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 |
8 |
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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510(K) Database |
510(K)s with Product Code = and Original Applicant = CARDIO-MED-ASSOCIATES, INC. 510(K)s with Product Code = and Original Applicant = CARDIO-PAK
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