STRADIS HEALTHCARE Eye Surgical Kits Recalled for Incomplete Sealing
STRADIS HEALTHCARE WECKCELL EYE SPEARS surgical kits (Item 9430, 9431) are recalled due to incomplete outer bag sealing that may compromise kit sterility. Approximately 80 kits distributed in the US and Canada are affected.
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 FDA Class II recall involves a risk-of-harm medical device where a significant manufacturing defect (incomplete sealing leading to potential sterility compromise) exists, but no injuries or illnesses have been reported. The hazard is potential but serious in a surgical context.
Plain-English summary
STRADIS HEALTHCARE WECKCELL EYE SPEARS are medical surgical procedure kits (Item Numbers 9430 and 9431) being recalled. The recall involves approximately 80 kits distributed nationwide in the United States and Canada.
During manufacturing, the outer bags of these kits may not have been completely sealed. An incomplete seal can result in a breach of the kit's sterility, which is essential for safe use in surgical procedures.
Affected kits include the following identifiers: Item 9430 with Lot 22270492023, and Item 9431 with Lots 22255491774 and 22255491484. Healthcare facilities and surgical centers that received these kits should identify affected inventory using these lot and serial numbers.
Healthcare providers should immediately discontinue use of affected kits and contact Stradis Medical, LLC dba Stradis Healthcare for instructions regarding return, replacement, or disposal. Do not use these kits in any surgical procedures.
The recalled product
- Product
- STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 80
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 (5)
- a) 9430: UDI/DI (case) M75294301
- UDI/DI (kit)M75294301
- Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301
- Serial/Lot Numbers: 22255491774
- 22255491484
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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