Agency classClass IIOur severity:Severe FDA (Devices)·Z-2116-2015·Announced 2015-07-29

FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves

The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.

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 compromised sterility in a medical device, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 144 sterile Augmentation Kits manufactured by Covidien LLC. The recall is due to the presence of splits or holes in the Devon Light Gloves contained within the kits, which compromises the sterility of the product.

The affected product is identified by the catalog number 573732 (7620-CWA Augmentation Kit). The recall applies to lots where the lot number begins with 508xxxx or lower. The product was distributed nationwide in the United States, including the Virgin Islands, as well as in Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, the Netherlands, Sweden, Ireland, Israel, Spain, Italy, Jordan, Kenya, Kuwait, the United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and the UAE.

Healthcare providers and consumers should stop using the affected kits immediately. Users should contact their supplier or the manufacturer for further instructions on how to return or dispose of the product.

The recalled product

Product: Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Gloves
Hazard: sterility-compromise
infection-risk
Affected units: 144

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)

Lot number begins 508xxxx or lower

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 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.

See all 14 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise