Surgical ocular packs recalled for loss of saline sterility
Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.
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 mandates a minimum score of 4, as sterility compromise in surgical applications creates a reasonable probability of serious infection. No deaths or hospitalizations are reported, preventing a Critical classification.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 128 units of Aligned Medical Solutions In House Ocular Pack (Model AMS12947A) with UDI B098AMS12947A0. Affected lot numbers are 192436, 192774, and 196582, distributed in Florida, Illinois, and California.
The saline solution included in these surgical kits cannot be guaranteed to remain sterile. Saline used in ocular surgery must be sterile to prevent bacterial and fungal infection. Non-sterile saline in surgical applications poses a significant risk of post-operative infection.
Facilities and medical professionals who received these kits should not use them for procedures. The saline should be discarded and replaced with a verified sterile alternative. Healthcare providers should contact patients who may have received procedures using these kits and advise them to monitor for signs of post-operative infection.
The recalled product
- Product
- Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kit
- Affected units
- 128
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 (3)
- UDI: B098AMS12947A0/Lot #s: 192436
- 192774
- 196582
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.
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