Date Initiated by Firm |
March 11, 2024 |
Date Posted |
April 18, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1596-2024 |
Recall Event ID |
94248 |
510(K)Number |
K223041
|
Product Classification |
negative pressure wound therapy Powered suction pump - Product Code OMP
|
Product |
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
|
Code Information |
GTIN: (01)05000223501044
Lot Numbers:
1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044 |
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 |
6895 units |
Distribution |
Worldwide distribution - US Nationwide and the countries of Canada, Chile. |
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 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
|