Patient Personal Hygiene Kit
Dental · 21 CFR 872.6855
This device contains items given to an individual during their hospital stay.
Recent MDR events
12 adverse event reports on file
- BALLARD* 24-HOUR ORAL CARE KITDec 19, 2025MalfunctionAvanos Medical Inc8030647-2025-00141
- BALLARD 24-HOUR ORAL CARE KITAug 8, 2025MalfunctionAvanos Medical Inc.8030647-2025-00073
- AVANOS MEDICAL, INC.Jul 7, 2025InjuryAvanos Medical Inc.8030647-2025-00065
- AVANOS MEDICAL, INCMar 12, 2025MalfunctionAvanos Medical Inc.8030647-2025-00023
- AVANOS, BALLARD ORAL CAREMar 5, 2025MalfunctionAvanos Medical Inc.8030647-2025-00021
- KIT, INFANT MATERNITYAug 23, 2024InjuryMedline - Mexicali3015173212-2024-00003
- KIT, INFANT MATERNITYAug 23, 2024InjuryMedline - Mexicali3015173212-2024-00004
- Q-CAREJul 9, 2019MalfunctionSage Products, Llc8771351
- CARDINAL HEALTH PERSONAL CLEANSING CLOTH, NON-FLUSHABLE, SCEFeb 20, 2018MalfunctionYangzhou Perfect Daily Chemicals1423537-2018-00159
- SHORT TERM SWAB SYSTEMMar 17, 2015Sage Products, Llc4656695
Event type breakdown
Recalls
15 recall events for this product code
- Medline Industries, LPOpen, ClassifiedJun 17, 2026
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2499-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedMay 7, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2105-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedFeb 17, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-1410-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJan 12, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Z-1058-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMay 1, 2025
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Z-1712-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedDec 5, 2024
MEDLINE convenience kits labeled as:
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Z-0639-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedOct 23, 2024
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Z-0172-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 11, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Z-3115-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3038-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 28, 2024
Medline procedural kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2757-2024 · View FDA record ↗
Registered firms
51 firms currently registered for this product code
Cangzhou Lankang Medical Instruments Developing Co., Ltd.
Cangzhou Hebei, CN
Iimed Medical Mexicana S. De R.l. De C.v.
Reynosa Tamaulipas, MX
Centurion Medical Products, Lp
HOWELL, MI, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Xiantao Generalcare Protection Products Co.,ltd
Xiantao City Hubei, CN
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Oralkleen Llc
Phoenix, AZ, US
Zhejiang Yamei Medical Equipment Technology Co., Ltd.
Yang Jiao Lang Zin'an Town Zhejiang, CN
Medline Industries, Lp - Laredo
LAREDO, TX, US
Heitco, Inc.
Avon, OH, US
Top Corporation
ADACHI-KU Tokyo, JP
Rosemarie Products Company, Llc
Mason, OH, US
Care Line, Inc.
GREENBRIER, TN, US
Yizur Ltd
Hong Kong, HK
Medi-dyne Healthcare Products, Inc.
COLLEYVILLE, TX, US
Shanghai Huayue Packaging Products Co., Ltd.
FENGXIAN DISTRICT, SHANGHAI, CN
Yiwu Botai Import & Export
Yiwu Zhejiang, CN
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Ortho Arch Company Inc
Schaumburg, IL, US
Avanos Medical, Inc.
Alpharetta, GA, US
Tiger Medical Group
SHANGHAI, CN
Henan Baistra Medical Devices Limited
Zhengzhou Henan, CN
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.