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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 1,528
Distribution
Part of a larger recall action
This product is one of 4 recalled by Windstone Medical Packaging, Inc. 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 4 products in this recall →Related recalls
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