TOTAL 5mm SOLUTION KIT 41 GK401Recalls & reported problems

Applied Medical Resources Corporation · Kit Contains: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CFF12, 5x100 Kii Fios ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Jan 30, 2024Open, Classified
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
Z-1389-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`20607915127866`
Brand	TOTAL 5mm SOLUTION KIT 41
Model	GK401
Company	Applied Medical Resources Corporation
Product code	FHF · System, Evacuator, Fluid
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 7, 2024

Device type (GMDN): Laparoscopic irrigation/aspiration cannula

A rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single-lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device.

Other System, Evacuator, Fluid devices

TOTAL 5mm SOLUTION KIT 42 GK402
Applied Medical Resources Corporation · System, Evacuator, Fluid
1 recall0 reports
Suction Irrigation System C6001
Applied Medical Resources Corporation · System, Evacuator, Fluid
6 reports

All System, Evacuator, Fluid 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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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