Medical Closure Kit Recall: Sterility of Saline Cannot Be Guaranteed
Windstone Medical Packaging is recalling Aligned Medical Solutions Closure Kits due to inability to guarantee sterility of included saline. This FDA Class I recall affects 475 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: This recall meets FDA Class I classification criteria for medical devices, which mandates a minimum severity level of Severe (4) per the severity rubric. The inability to guarantee sterility of a component used in surgical procedures represents a serious patient safety risk.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Aligned Medical Solutions Closure Kits (model AMS13043, STERILEEO) distributed in the United States. The closure kits are recalled because sterility assurance for the saline included in them cannot be guaranteed.
The recall affects 475 closure kits distributed in Florida, Illinois, and California. The affected lot numbers are 178114, 187325, 191102, 195504, 196502, and 197864. The product's UDI is B098AMS130430.
Saline that cannot be guaranteed sterile poses a potential infection risk if used in surgical procedures. This is classified as an FDA Class I recall, the most serious classification level for medical device recalls.
The recalled product
- Product
- Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- sterility-failure
- infection-risk
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 (1)
- UDI: B098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864
Distribution
Distributed in 3 states:
- CA
- FL
- IL
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