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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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.
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