Surgical ocular pack kits recalled due to saline sterility assurance loss
Windstone Medical Packaging is recalling 80 Aligned Medical Solutions ocular pack surgical kits because sterility of the included saline cannot be guaranteed.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates a reasonable probability of serious adverse health consequences. Loss of sterility assurance for saline in surgical kits is classified by FDA as Class I, meeting the critical severity threshold.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Aligned Medical Solutions In House Ocular Pack, model AMS12947, STERILEEO surgical kits because the sterility assurance for the saline solution included in the kits cannot be guaranteed.
The recall affects 80 kits distributed in the United States in Florida, Illinois, and California. The affected lot numbers are 192389 and 194805 (UDI: B098AMS129470).
Consumers who have received these kits should stop using them and contact their healthcare provider or Windstone Medical Packaging immediately.
The recalled product
- Product
- Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Ocular Surgical
- Hazard
- sterility-failure
- contamination-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: B098AMS129470/ Lot #s: 192389 and 194805
Distribution
Distributed in 3 states:
- CA
- FL
- IL
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