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.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 80
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
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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