Minor Surgical Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling Minor Surgical Kits containing Devon Light Gloves with splits or holes that compromise 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 risk-of-harm product (sterile medical device) where sterility is compromised, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove. The recall is due to the presence of splits or holes in the gloves, which compromises the sterility of the kits.
The affected products are manufactured by Covidien LLC. The specific catalog numbers involved are 573208, 573210, 573741, 31144507, and 573830D. The recall covers 81,252 kits with lot numbers beginning with 508xxxx or lower. These products were distributed worldwide, including the United States (nationwide and Virgin Islands), Canada, Australia, New Zealand, and numerous countries in Europe, the Middle East, Africa, and Asia.
Healthcare facilities and consumers should stop using these kits immediately. Users should check their inventory for the specific catalog numbers and lot numbers listed above. If the products are found, they should be returned to the supplier or the manufacturer for credit or replacement.
The recalled product
- Product
- Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 81,252
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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