Agency classClass IIOur severity:Severe FDA (Devices)·Z-2110-2015·Announced 2015-07-29

Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves

FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising 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 (sterility compromise) poses a significant risk of infection or injury to patients, meeting the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration is recalling 33,256 Surgical Set Up kits manufactured by Covidien LLC. The recall is due to the presence of splits or holes in the Devon Light Gloves contained within the sterile kits, which compromises the sterility of the product.

The affected products include various Single Basin and Double Basin Set Up Kits, as well as specific Surgical Set Up Kits with catalog numbers such as 31144895, 31144960, and 31153938. The recall applies to lots where the lot number begins with 508xxxx or lower.

The products were distributed worldwide, including the United States (nationwide and Virgin Islands), Canada, Australia, New Zealand, and numerous countries in Europe, the Middle East, and Africa. Users should stop using the affected kits and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897…
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Kits
Hazard: sterility-compromise
infection-risk
Affected units: 33,256

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