FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves
The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with 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 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 defect compromises the sterility of medical devices used in surgical procedures, posing a significant risk of infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling sterile delivery and C-section 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 products include specific catalog numbers for C-Section and Delivery Kits, such as 7335-SMC C-Section Kit, 7382-OTO2 Delivery Kit, and 7339-ES C-SECTION DELUXE PACK. The recall covers 8,630 units distributed worldwide, including the United States, Canada, Australia, and numerous other countries. The affected lot numbers begin with 508xxxx or lower.
Healthcare facilities and consumers should stop using these kits immediately and contact the manufacturer for instructions on return or replacement. The defect in the gloves poses a risk of infection due to the loss of sterility.
The recalled product
- Product
- Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 8,630
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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