Stradis Healthcare surgical procedure kits recalled for incomplete outer bag sealing
Stradis Healthcare has recalled surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. Affected units (40 units, lot 22235489419) were distributed across the United States and Canada.
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 surgical procedure kits with potential breach of sterility from incomplete packaging seals. No reported illnesses or injuries; this is classified as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE Surgery PK surgical procedure kits (Item No. 682-1728) distributed in the United States and Canada. The recall involves 40 units with serial/lot number 22235489419.
The kits were produced under manufacturing conditions that may result in incomplete sealing of the outer bag. An incompletely sealed bag may result in a breach of the kit's sterility, potentially compromising the safety of the contents.
Customers using or possessing affected kits should stop using them immediately. The recalled products can be identified by UDI/DI (case) M75268217281, UDI/DI (kit) M75268217280, and serial/lot number 22235489419. Affected customers should contact Stradis Healthcare for further information regarding returns, replacements, or proper disposal.
The recalled product
- Product
- STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 40
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) M75268217281
- UDI/DI (kit)M75268217280
- Serial/Lot Numbers: 22235489419
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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