Surgical Kit with Saline Recalled Over Sterility Assurance Issue
Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates serious potential for adverse health consequences. Loss of sterility assurance in saline for surgical use creates significant risk of post-operative infection. No illnesses or deaths are reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling the Aligned Medical Solutions Local Lower Extremity Pack I, a surgical kit containing saline. The recall affects 1,528 units distributed in the United States.
The FDA classified this as a Class I recall because sterility assurance cannot be guaranteed for the saline included in the surgical kits. Non-sterile saline poses a risk of infection when used in surgical procedures.
The affected product was distributed in Florida, Illinois, and California. Multiple lot numbers are involved in the recall. Healthcare facilities and providers should immediately discontinue use of affected units and contact Windstone Medical Packaging for instructions on return or replacement.
More information is available from the FDA regarding this recall.
The recalled product
- Product
- Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kit
- Hazard
- sterility-assurance
- infection-risk
Distribution
Distributed in 3 states:
- CA
- FL
- IL
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