Agency classClass IIOur severity:Severe FDA (Devices)·Z-2113-2015·Announced 2015-07-29

FDA Recalls Sterile Double Basin Kits with Compromised Devon Light Gloves

The FDA is recalling 5,786 sterile Double Basin Kits because the included Devon Light Gloves contain 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, which corresponds to a Severe rating (Score 4) under the rubric, as it involves a defect that could cause temporary or medically reversible health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 5,786 units of the Double Basin Kit, a sterile kit containing the Devon Light Glove. The recall is being conducted by the manufacturer, Covidien LLC. The affected products are identified by catalog numbers 31145504 (7708 Double Basin Kit), 50007898 (7898-T8 Double Basin Kit), and 50007899 (7899-T8 Double Basin Kit). The specific lots affected are those where the lot number begins with 508xxxx or lower.

The reason for the recall is that the Devon Light Gloves contained in these kits have splits or holes that compromise the sterility of the product. This defect poses a risk of infection or other adverse health consequences if the non-sterile gloves are used in a clinical setting.

The affected kits were distributed worldwide, including nationwide in the United States (including the Virgin Islands) and in numerous international locations such as Canada, Australia, New Zealand, and various countries in Europe, the Middle East, and Africa. Healthcare facilities and consumers who have these specific kits should stop using them immediately and contact the manufacturer or their supplier for instructions on return or replacement.

The recalled product

Product: Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Gloves / Kits
Hazard: sterility-compromise
infection-risk
Affected units: 5,786

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 14 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise