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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where sterility is compromised, creating a risk of infection (risk-of-harm product) without reported injuries in the source text, which aligns with the 'High' severity criteria.
Plain-English summary
Covidien LLC is recalling Curity Eye Pad Oval, Item Code 2841, due to a breach of the sterile barrier. This defect compromises the sterility of the device, which is intended to be used as a sterile bandage over the eye for protection or absorption of secretions, particularly in operating rooms or following injury and surgery.
The recall affects approximately 24,765,540 units. The affected lots have lot numbers beginning with 12, 13, 14, 15, or 16 and expiration dates ranging from February 2017 through November 2021. The products were distributed worldwide, including in the United States, Canada, Australia, and numerous other countries.
Consumers and healthcare providers should stop using the affected eye pads and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 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 secr
- Manufacturer
- Covidien LLC
- Affected units
- 24,765,540
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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