Covidien LLC: Product sterility is compromised due to breach of sterile barrier

Agency Publication Date: March 27, 2017

Affected Products

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 in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Lot Numbers:

Number

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 secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Lot Numbers:

Number

Product: Covidien Curity Eye Pad Item Code: 91650 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 in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Lot Numbers:

Number

Product: Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.

Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number

Product: Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.

Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number

Product: Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds

Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number

Product: Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.

Lot Number beginning with: 14, 15, 16 *Exclude lots 16J098062 16J098162 16J098262 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76606

Status: Resolved

Manufacturer: Covidien LLC

Manufactured In: United States

Units Affected: 7 products (7168000; 24765540; 1659500; 104688; 38794; 168824; 1222080)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Lot Numbers:

Number

Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Lot Numbers:

Number

Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Lot Numbers:

Number

Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number

Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number

Product: Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds

Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number

Lot Number beginning with: 14, 15, 16 *Exclude lots 16J098062 16J098162 16J098262 Expiration Date: From February 2017 through November 2019

Lot Numbers:

Number