Recall of Sterile Major Kits with Defective Devon Light Gloves
FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.
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 3/5 (High).
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 (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling sterile Major Kits manufactured by Covidien LLC. The recall is due to the presence of Devon Light Gloves within the kits that contain splits or holes, which compromises the sterility of the product.
The affected product is the Major Kit, Sterile, Catalog Number 573831B. The recall involves 5,160 kits. The distribution pattern includes the United States (nationwide, including the Virgin Islands) and numerous international locations, including Canada, Australia, New Zealand, and various countries in Europe, the Middle East, and Africa.
Healthcare facilities and consumers should stop using these kits and contact the manufacturer or the FDA for further instructions. The specific lot numbers affected are those beginning with 508xxxx or lower.
The recalled product
- Product
- Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 5,160
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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