Medical and Surgical Procedure Trays Recalled for Incomplete Seal
Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were 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 for a medical device with potential for patient harm due to sterility breaches. No illnesses or injuries have been reported. The incomplete seal poses a theoretical risk that meets the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Henry Schein Basic Pack medical and surgical procedure trays and kits due to a manufacturing defect.
The recalled products underwent manufacturing conditions that may result in the outer bag being incompletely sealed. An incomplete seal may breach the sterility of the kit.
The affected product was distributed to customers in the United States and in Canada.
Customers who have received this product should stop using it and contact the manufacturer for instructions regarding the recall.
The recalled product
- Product
- HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 24
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) H65857027181
- UDI/DI (kit)M75257027180
- Serial/Lot Numbers: 22242489582
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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