Z-1107-2024 Class I Ongoing
FDA device recall Z-1107-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 15, 2023 and is designated Class I. Reason for recall: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for… The recall status is ongoing. Affected quantity: 10391 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2024
- Initiation Date
- Nov 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10391 units
Product Description
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Reason for Recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Distribution Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Code Information
a) REF MNS10750A, UDI/DI 00653160348286 (case), 10653160348283 (unit), Lot Numbers: 2022032150, 2022053150, 2022061750, 2022073050; b) REF DT21235A, UDI/DI 00653160348453 (case), 10653160348450 (unit), Lot Numbers: 2022012701; c) REF DYNDC3166A, UDI/DI 00653160350111 (case), 10653160350118 (unit), Lot Numbers: 2022021150, 2022031450, 2022031850
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1107-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026