Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing
Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 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 a Class II medical device recall with no reported illnesses or injuries. The hazard is a potential sterility breach due to incomplete sealing—a risk-of-harm scenario where injury has not yet been reported, placing it in the High severity category per the rubric.
Plain-English summary
Stradis Medical, LLC (doing business as Stradis Healthcare) is recalling Henry Schein Custom PK 2 surgical procedure kits (Item No. 570-3072). The recall affects 27 units that were distributed nationwide in the United States and Canada.
The affected kits underwent certain manufacturing conditions that may have resulted in the outer bag being incompletely sealed. An incompletely sealed outer bag can result in a breach of the kit's sterility, which is essential for safe surgical use.
Healthcare providers who received these kits should discontinue use immediately. Contact the manufacturer for instructions on return or replacement of the affected units.
The recalled product
- Product
- HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 27
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) H65857030721
- UDI/DI (kit)M75257030720
- Serial/Lot Numbers: 22241490953
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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