INTERNATIONAL MEDICAL PRODUCTS, INC.

Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-HEMO-15G, 100/CS, LOT #B1128, EXP 8-12, BIN 34A, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-C, 100/CS, LOT #B1134, EXP 8-12, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-H, 75/CS, LOT #B1135, EXP 8012, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12, 100/CS, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, 100/CS, LOT #B1148, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 SNCH-CATH, 50/CS, LOT #B1152, EXP 8-12, BIN 43A, Lee Medical International, Inc., New Orleans, LA 70123 COMMUNITY-HEMO, 125/CS, LOT #B1156, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 FLAMS-HEMO, 125/CS. LOT #B1162, EXP 8-12, BIN 38B, Lee Medical International, Inc., New Orleans, LA 70123 KINDEYSPA-HEMO, 125/CS, LOT #B1161, EXP 8-12, BIN 35B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1107, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-CATH, 75/CS, LOT #C1108, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #C1109, EXP 9-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #C1110, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KIDNEYTRMT-HEMO, 125/CS, LOT #C1112 and C1123, EXP 9-12, BIN 45A, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1126, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 METHODIST-HEMO, 150/CS, LOT #C1139, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KINGMAN-HEMO, 150/CS, LOT #C1141, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-PALMERTON-H, 200/CS, LOT #C1145, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 EMANUEL-CATH, 100/CS, LOT #C1146, EXP 9-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 Product Usage: custom dialysis prep kits

FDA Recall

Terminated ·Lee Medical International Inc·Product code FKG·March 22, 2011

POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

FDA Enforcement

Class II ·Terminated·POM Medical LLC·November 6, 2019

CORTRAK2 NG/NI FEED TUBE, ELECTROMAGNETIC TRANSMIT STYLET, ENFIT

FDA Adverse Event

Malfunction ·AVANOS MEDICAL INC.·Product code KNT·May 23, 2025

MIC SAFETY PEG KIT WITH ENFIT CONNECTORS-20 FR-PULL

FDA Adverse Event

Malfunction ·AVANOS MEDICAL INC.·Product code KNT·July 11, 2025

MIC SAFETY PEG KIT WITH ENFIT CONNECTORS-20 FR-PUSH OTW

FDA Adverse Event

Malfunction ·AVANOS MEDICAL INC.·Product code KNT·July 11, 2025

PINNACLE®

FDA Adverse Event

Malfunction ·B. BRAUN MEDICAL INC.·Product code NEP·April 14, 2022

DESIGN OPTIONS®

FDA Adverse Event

Malfunction ·B. BRAUN MEDICAL INC.·Product code OGE·April 10, 2026

INTROCAN SAFETY®

FDA Adverse Event

Injury ·B. BRAUN MELSUNGEN AG·Product code FOZ·April 15, 2019

MIC SAFETY PEG KIT WITH ENFIT CONNECTORS-20 FR-PUSH OTW

FDA Adverse Event

Malfunction ·AVANOS MEDICAL INC.·Product code KNT·July 11, 2025

MIC SAFETY PEG KIT WITH ENFIT CONNECTORS-20 FR-PULL

FDA Adverse Event

Malfunction ·AVANOS MEDICAL INC.·Product code KNT·July 11, 2025

Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

FDA Enforcement

Class I ·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014

INFUSOMAT®

FDA Adverse Event

Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·November 10, 2021

CORFLO PEG KIT WITH ENFIT CONNECTOR

FDA Adverse Event

Malfunction ·AVANOS MEDICAL INC.·Product code KNT·October 22, 2021

INFUSOMAT SPACE

FDA Adverse Event

Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·November 11, 2016

APEX¿

FDA Adverse Event

Malfunction ·B. BRAUN AVITUM ITALY S.P.A.·Product code KPE·May 1, 2019

INTROCAN SAFETY®

FDA Adverse Event

Death ·B. BRAUN MELSUNGEN AG·Product code FOZ·April 15, 2019

CORFLO SAFETY PEG KIT - PULL METHOD

FDA Adverse Event

Malfunction ·AVANOS MEDICAL INC.·Product code KNT·August 22, 2019

INFUSOMAT®

FDA Adverse Event

Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·November 9, 2021

ACCESSORIES FOR SPACE PUMP

FDA Adverse Event

Malfunction ·B. BRAUN MELSUNGEN AG·Product code MRZ·April 7, 2016

PINNACLE®

FDA Adverse Event

Malfunction ·B. BRAUN MEDICAL INC.·Product code NEP·August 4, 2023