Cystoscopy kits recalled for potential sterility breach from packaging defects
Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.
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 involving a potential sterility breach in surgical kits due to packaging defects. No illnesses or injuries have been reported; however, compromised sterility in medical devices used for invasive procedures presents a risk of harm.
Plain-English summary
The Henry Shein CYSTO SET UP PACK is a medical device cystoscopy kit distributed by Henry Shein and manufactured by Stradis Healthcare.
The recall addresses a potential for pinhole leaks in the outer bag near the seal. These leaks could result in a breach of the kit's sterility.
Approximately 1,040 units have been distributed nationwide, including in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. The affected lot numbers are: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, and 222992161.
The recalled product
- Product
- Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
- Manufacturer
- Stradis Healthcare
- Affected units
- 1,040
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 (12)
- Assembly Number 570-1130
- UDI-DI: H65857011301
- Lot Numbers: 222990332
- 222692396
- 222990334
- 221013080
- 222529321
- 220984273
- 222692395
- 222368551
- 220982614
- 222992161.
Distribution
Part of a larger recall action
This product is one of 18 recalled by 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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