Recall of Sterile Eye Pads Due to Compromised Sterility Barrier
Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, and the hazard involves a breach of the sterile barrier for a device used in surgical or post-injury contexts, which carries a significant risk of infection.
Plain-English summary
Covidien LLC is recalling Curity Eye Pads (Item Code 03201) because the product sterility is compromised due to a breach of the sterile barrier. The sterile eye pads are intended for use as a bandage over the eye for protection or absorption of secretions, particularly in operating rooms or following injury and surgery to reduce the likelihood of infection.
The recall affects 7,168,000 units distributed worldwide, including the United States, Canada, Australia, and numerous other international markets. The affected lots have numbers beginning with 12, 13, 14, 15, or 16, with expiration dates ranging from February 2017 through November 2021.
Consumers and healthcare providers should stop using the affected eye pads and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
- Manufacturer
- Covidien LLC
- Affected units
- 7,168,000
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 (5)
- Lot Number beginning with: 12
- 13
- 14
- 15
- 16 Expiration Date: From February 2017 through November 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Covidien LLC 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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