Date Initiated by Firm | April 29, 2011 |
Date Posted | May 27, 2011 |
Recall Status1 |
Terminated 3 on May 29, 2015 |
Recall Number | Z-2393-2011 |
Recall Event ID |
58665 |
510(K)Number | K770789 |
Product Classification |
Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
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Product | URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe
Product ID: 8884732500
Intended use: Collector urine from male patients (and accessories) for indwelling catheter |
Code Information |
Lot Numbers: 016671464 019371364 022372464 023072264 027272564 032972964 034172164 100370964 103170664 106855364 |
Recalling Firm/ Manufacturer |
Covidien LP 15 Hampshire St Mansfield MA 02048-1113
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For Additional Information Contact | Jim Welsh 508-261-8000 |
Manufacturer Reason for Recall | A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination |
FDA Determined Cause 2 | Other |
Action | The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated April 29, 2011 to its customers via US Postal Service. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the product, place in quarantine, and return any inventory. Distributors are requested to notify their customers. All customers are required to respond to the notice regardless of remaining inventory. Responses will be tracked for follow-up and effectiveness checks.
For Customer Service questions regarding the recall please telephone: 1-800-962-9888 option 1 (weekdays, 8am to 6:30pm Eastern) and email to: sdfeedback@covidien.com. Should you have any medical questions concerning this recall, please call 508-261-6393. |
Quantity in Commerce | 52128 units |
Distribution | Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda. |
Total Product Life Cycle | TPLC Device Report |
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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 = KNX
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