Stradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach
Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. Affected units were distributed 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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—a potential sterility breach based on manufacturing defects that may result in incomplete sealing. Per the rubric, recalls with no reported illnesses and theoretical hazards score at most 3.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Venous Access Pack kits (Item No. 682-1993R1) with lot number 22235491208. The kits underwent manufacturing conditions that may result in the outer bag being incompletely sealed, which could compromise the sterility of the kit.
These medical and surgical procedure kits were distributed nationwide in the United States and in Canada. No illnesses or injuries have been reported related to this recall.
The recalled product
- Product
- STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kits
- Affected units
- 30
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) M7526821993R11
- UDI/DI (kit)M7526821993R10
- Serial/Lot Numbers: 22235491208
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.
See all 78 products in this recall →Related recalls
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