Medical Procedure Trays Recalled for Potential Sterility Breach
Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.
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. The source text does not report any illnesses, injuries, or deaths. The hazard—potential sterility breach due to incomplete sealing—represents a theoretical risk to patients. Per the rubric, recalls of risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Stradis Healthcare is recalling 100 units of the Henry Schein CATH PACK (Item No. 570-2789), a medical and surgical procedure tray and kit. The recall is due to manufacturing conditions that resulted in some outer bags being incompletely sealed.
An incompletely sealed outer bag may result in a breach of the kit's sterility. Because these devices are intended for use in sterile medical and surgical procedures, any compromise to the sterile barrier poses a potential patient risk.
The affected products were distributed nationwide in the United States and to Canada. Healthcare facilities and providers who have received these kits should discontinue use and contact Stradis Healthcare for instructions on product replacement or return.
The recalled product
- Product
- HENRY SCHEIN, CATH PACK Item No.570-2789
- 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) H65857027891
- UDI/DI (kit)M75257027890
- Serial/Lot Numbers: 22252491561
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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