Endovenous Procedure Packs Recalled for Incomplete Bag Sealing
Stradis Healthcare is recalling Endovenous Packs due to incompletely sealed outer bags that may compromise kit sterility. No illnesses have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving risk-of-harm product (sterility breach in surgical procedure kits). No illnesses or injuries reported, but the potential for contamination from incomplete sealing represents significant risk to patient safety.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Endovenous Packs (Item No. 682-494) distributed nationwide in the US and Canada. The surgical procedure trays underwent manufacturing conditions that may result in incompletely sealed outer bags.
An incompletely sealed outer bag may allow a breach in the kit's sterility. This could expose the sterile contents to potential contamination during storage or handling. No illnesses or injuries related to this issue have been reported.
Healthcare facilities and medical professionals who received these kits should discontinue use and contact Stradis Healthcare for replacement or return instructions. Patients who may have received treatment with these kits should contact their healthcare provider if they have concerns.
The recalled product
- Product
- www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI (case) M7526824941
- UDI/DI (kit)M7526824940
- Serial/Lot Numbers: 22234489198
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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