Agency classClass IIOur severity:High FDA (Devices)·Z-0015-2019·Announced 2018-10-10

Kerlix Gauze Rolls Recalled for Potential Sterility Breach

COVIDIEN LLC is recalling Kerlix Gauze Rolls due to a potential seal defect that could 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 medical device with a potential sterility breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

COVIDIEN LLC is recalling Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880. The recall involves 2,730,821 units distributed nationwide in the United States. The affected lot numbers are 18E030462, 18E223262, and 18F122962.

The recall was initiated due to a potential for product sterility breach caused by a compromised or pinched seal defect. These products are used as both primary and secondary dressings for bandaging heads, limbs, and difficult-to-dress wounds.

Consumers and healthcare facilities should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the recalling firm, COVIDIEN LLC, in accordance with their instructions.

The recalled product

Product: Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Manufacturer: COVIDIEN LLC
Category: Medical Device — Surgical Dressings
Hazard: sterility-breach
infection-risk
Affected units: 2,730,821

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 (3)

Lot Numbers: 18E030462
18E223262
18F122962

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · COVIDIEN LLC

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Same hazard · sterility breach