Medical and Surgical Procedure Trays Recalled Due to Incomplete Sealing
Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.
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 for sterile surgical kits with risk of sterility compromise and contamination. Meets the rubric criterion for risk-of-harm products where no illnesses or injuries have been reported.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling medical and surgical procedure kits distributed under the Henry Schein brand with item number 570-2779. The kits are distributed nationwide in the United States and in Canada, affecting 90 units.
The outer packaging of these kits may be incompletely sealed due to manufacturing conditions, which could result in a breach of the sterility of the kit. A compromised sterile barrier could allow contamination of the medical and surgical equipment contained within, potentially exposing patients to infection.
Healthcare facilities and professionals using these kits should stop use immediately and contact Stradis Medical for instructions on returns or replacement. The affected lot and serial numbers are 22262489585 and 22270490757.
The recalled product
- Product
- HENRY SCHEIN, OMFS, Item No.570-2779,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 90
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 (4)
- UDI/DI (case) H65857027791
- UDI/DI (kit)M75257027790
- Serial/Lot Numbers: 22262489585
- 22270490757
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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