RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it
Summary
The FDA issued a Class II for RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would be by Smith & Nephew Medical, Ltd.. Reason: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump.
Details
Source
Device Recall
External ID
Z-1596-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044
Quantity Affected: 6895 units
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-11
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smith & Nephew Medical, Ltd. has 7 FDA actions in our database, including 3 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smith & Nephew Medical, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smith & Nephew Medical, Ltd. have FDA actions?
Smith & Nephew Medical, Ltd. has 7 FDA actions in our database, including 3 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1596-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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