Angioplasty Procedure Trays Recalled Due to Incomplete Bag Sealing
Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.
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: This is an FDA Class II recall for a medical device with a risk-of-harm component (potential sterility breach) where no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling medical and surgical procedure trays and kits used in angioplasty procedures. The recall affects 100 units that underwent manufacturing conditions resulting in incomplete sealing of the outer packaging.
The incomplete sealing of the outer bag may result in a breach of the kit's sterility, potentially compromising the integrity of the medical device during use. Sterile surgical kits are essential for preventing contamination and infection risk during medical procedures. The affected trays and kits were distributed throughout the United States and Canada, with Lot/Serial Number 22237490509.
Healthcare facilities and medical professionals who have received these units should quarantine them immediately and discontinue their use in patient procedures. Contact Stradis Healthcare for instructions on product replacement or proper disposal. No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 100
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) M75268219371
- UDI/DI (kit)M75268219370
- Serial/Lot Numbers: 22237490509
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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