Medical and surgical procedure kits recalled for potential sterility loss
Stradis Medical is recalling Henry Schein Basic Extended Pack procedure kits due to incomplete sealing of the outer bag, which may compromise sterility. Products were distributed 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: FDA Class II recall of medical device with potential for serious harm due to incomplete sealing and possible sterility breach. No illnesses or injuries reported. Per rubric criteria, this is a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Stradis Medical, LLC, doing business as Stradis Healthcare, is recalling the HENRY SCHEIN BASIC EXTENDED PACK (Item No. 570-2890), a medical and surgical procedure tray and kit. The recalled product consists of 25 units with serial/lot number 22262492001.
During manufacturing, certain production conditions resulted in the outer bag being incompletely sealed. This incomplete seal may allow a breach in the sterility of the kit, potentially exposing the contents to contamination.
The product was distributed nationwide throughout the United States and Canada. For questions or additional information regarding this recall, contact the FDA or Stradis Medical.
The recalled product
- Product
- HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 25
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) H65857028901
- UDI/DI (kit)M75257028900
- Serial/Lot Numbers: 22262492001
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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