Medical Procedure Trays Recalled for Incomplete Outer Bag Sealing
Stradis Healthcare recalls Henry Schein Rhino Pack surgical trays due to potentially incomplete outer bag sealing that may compromise kit sterility. The recall affects 328 units distributed in the US and Canada.
What this means for you
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 medical device recall involving a potential sterility breach due to incomplete sealing. The source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling 328 units of the Henry Schein Rhino Pack (Item No. 570-3070), medical and surgical procedure trays and kits. The recall was initiated due to manufacturing conditions that may result in the outer bag being incompletely sealed.
An incompletely sealed outer bag may result in a breach of the sterility of the kit. This creates a potential risk of contamination that could compromise product integrity when used in medical or surgical procedures.
The affected product was distributed nationwide in the United States and to Canada. Affected lot and serial numbers include 22235491255 and 22241491256. Healthcare providers and facilities who have received this product should cease use and contact Stradis Healthcare or their distributor for return and replacement instructions.
The recalled product
- Product
- HENRY SCHEIN, RHINO PACK, Item No.570-3070
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- incomplete-seal
- sterility-breach
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 (4)
- UDI/DI (case) H65857030701
- UDI/DI (kit)M75257030700
- Serial/Lot Numbers: 22235491255
- 22241491256
Distribution
Distributed nationwide across the United States.
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