Kerlix 4048Recalls & reported problems

Cardinal Health, Inc. · X-Ray Detectable Laparotomy Sponges,Tray Pack · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884527020850), received between Jun 25, 2019 and Jun 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Device Misassembled During Manufacturing /Shipping1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 25, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTS LAP SPONGES IS PACKAGED 5 PER TRAY, BUT THIS TRAY CONTAINED 6 LAP SPONGES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8732858 ↗

Device details

UDI-DI	`10884527020850`
Brand	Kerlix
Model	4048
Company	Cardinal Health, Inc.
Product code	GDY · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 24, 2021

Device type (GMDN): Radiopaque woven surgical sponge

A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

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All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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