Recall Z-0563-2024 ยท NSB Patient Personal Hygiene Kit
MEDLINE INDUSTRIES, LP - Northfield
(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
| Date | Dec 22, 2023 (initiated Oct 16, 2023) |
| Status | Open, Classified |
| Reason | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued "MEDICAL DEVICE RECALL" letters dated 10/16/2023 via first class mail and email explaining the reason for recall and the required actions that needed to be taken. The actions for consignees to take included checking their stock for the affected item numbers and affected lot numbers which are located within the recall portal; using the link, https://recalls.medline.com, provided in the letter to complete the response form with the quantity of affected product in inventory; and destroy the affected inventory for credit. If the consignee is a distributor who has resold |
| Quantity | 550 kits |
| Distribution | US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.