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U.S. Department of Health and Human Services

Class 2 Device Recall RENASYS EDGE Canister

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  Class 2 Device Recall RENASYS EDGE Canister see related information
Date Initiated by Firm March 11, 2024
Date Posted April 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-1597-2024
Recall Event ID 94248
510(K)Number K223041  
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
Product RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing
Product Number: 66803140
Code Information GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
Recalling Firm/
Manufacturer		 Smith & Nephew Medical, Ltd.
101 Hessle Road
Hull United Kingdom
For Additional Information Contact David Snyder 150 Minuteman Road Andover, MA 01810 (978)
978-749-1440
Manufacturer Reason
for Recall		 Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
FDA Determined
Cause 2		 Under Investigation by firm
Action Smith & Nephew Medical Ltd. issued Urgent Medical Device Recall Notice R-2024-02 on March 11, 2024 via overnight mail. Letter states reason for recall, health risk and action to take: Based on the regulatory classification and degree of hazard, this field action extends to the retail level. Therefore, it is not required to communicate this notice to the patient at the consumer level. If your customer contacts you regarding a pump failure: 1. Contact S+N Clinical Hotline (800-876-1261) with any questions. 2. Please ensure you provide a replacement as soon as possible. Replacement Stock. Smith+Nephew is supplying replacement stock quantities in parallel with this notice. Please contact AWM.returns.cr@smith-nephew.com if you have any questions. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Quantity in Commerce 675 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Chile.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OMP and Original Applicant = Smith & Nephew Medical Limited
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