FDA Recalls Sterile Single Basin Kits with Compromised Gloves
The FDA is recalling 77,588 sterile single basin kits because the Devon Light Gloves contain 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 is classified as FDA Class II, and the hazard involves a risk of harm (infection) from compromised sterility, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 77,588 units of Single Basin Kits, Sterile, manufactured by Covidien LLC. The recall is due to a defect where the Devon Light Gloves contained in the kits have splits or holes, which compromises the sterility of the product.
The affected products include various catalog numbers such as 573509, 573558, 573561, 31145645, 31153060, 50000568, 50000599, 50007698, and 50007699. The recall applies to lots where the lot number begins with 508xxxx or lower. These kits were distributed worldwide, including in the United States (nationwide), the Virgin Islands, Canada, Australia, New Zealand, and numerous other countries.
Healthcare facilities and consumers should stop using these kits and contact the manufacturer or the FDA for further instructions. The defect poses a risk of infection due to the loss of sterility.
The recalled product
- Product
- Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 77,588
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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