Single-shot epidural kits recalled due to incomplete outer bag sealing
Stradis Medical is recalling 80 Henry Schein single-shot epidural kits due to potentially incomplete outer bag sealing that could compromise sterility. The recall affects units distributed nationwide in the US 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: This is an FDA Class II recall of medical procedure kits with a potential sterility breach. No illnesses or injuries have been reported, so the severity is limited to High per the rubric's criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC (doing business as Stradis Healthcare) is recalling 80 Henry Schein single-shot epidural kits (Item No. 570-3089) distributed in the United States and Canada. The recall was initiated due to manufacturing conditions that may result in the outer bag being incompletely sealed.
The incomplete sealing of the outer bag may result in a breach of the kit's sterility. Compromised sterility in medical devices used for invasive procedures could potentially expose patients to infection risk during epidural administration.
Affected kits have the UDI/DI (case) H65857030891, UDI/DI (kit) M75257030890, and Serial/Lot Number 22251491690. Healthcare providers should stop using affected units immediately and contact Stradis Medical for instructions regarding return or replacement of the recalled kits.
The recalled product
- Product
- HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- Affected units
- 80
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) H65857030891
- UDI/DI (kit)M75257030890
- Serial/Lot Numbers: 22251491690
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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