Henry Schein Pacemaker Surgical Kits Recalled for Sterility Concerns
Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.
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: Sterility compromise in surgical procedure kits presents a risk of harm to patients, as breached sterile packaging can lead to serious infections. No illnesses or injuries have been reported. This meets the criteria for Score 3 (High) as a risk-of-harm product with no reported injury.
Plain-English summary
Stradis Medical, LLC (operating as Stradis Healthcare) is recalling certain Henry Schein Pacemaker Pack I surgical procedure kits (Item No. 570-2793). The recall affects 18 units distributed nationwide in the United States and Canada.
During manufacturing, the outer bags of these kits may have been incompletely sealed. An incomplete seal can result in a breach of the sterile packaging, which is essential for maintaining the safety and efficacy of surgical instruments and supplies.
Healthcare facilities and medical professionals who received these kits should identify affected units using the provided lot and UDI information (Lot 22241489575, UDI/DI case H65857027931, UDI/DI kit M75257027930). Contact Stradis Medical, LLC dba Stradis Healthcare for guidance on handling recalled units.
The recalled product
- Product
- HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 18
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) H65857027931
- UDI/DI (kit)M75257027930
- Serial/Lot Numbers: 22241489575
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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