Patient Personal Hygiene Kit
FDA product code NSB · Class I (low risk) · 21 CFR 872.6855 · Dental
This device contains items given to an individual during their hospital stay.
0510(k) clearances
0PMA approvals
16recalls
GMP exemptexempt from GMP rules
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3075-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-2499-2026 Class II | MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2105-2026 Class II | Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1410-2026 Class II | Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1058-2026 Class II | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-1712-2025 Class II | Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001AIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… | MEDLINE INDUSTRIES, LP - Northfield | 03/19/2025Open, Classified |
| Z-0639-2025 Class II | MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0172-2025 Class II | Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-3115-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | MEDLINE INDUSTRIES, LP - Northfield | 06/27/2024Open, Classified |
| Z-3038-2024 Class II | Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2757-2024 Class II | Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-1121-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-0563-2024 Class I | (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training…The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use… | MEDLINE INDUSTRIES, LP - Northfield | 10/16/2023Open, Classified |
| Z-2330-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1087-2023 Class II | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-2139-2019 Class II | Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in…A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium… | Sage Products Inc | 12/05/2018Terminated |