Z-1122-2024 Class I Ongoing
FDA device recall Z-1122-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 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 Irrigatio… The recall status is ongoing. Affected quantity: 2903 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- November 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2903 units
Product Description
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
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 CDS980273D, UDI/DI 40884389851808 (case), 10884389851807 (unit), Lot Numbers: 22DBJ834; b) REF DYNJ907794, UDI/DI 40193489884952 (case), 10193489884951 (unit), Lot Numbers: 22BBB085, 22CBW699, 22FBH326, 22KBJ007, 22KBW578, 23ABL612, 23CBT573, 23HBD177; c) REF DYNDL1864A, UDI/DI 40889942721420 (case), 10889942721429 (unit), Lot Numbers: 22FBN858, 22IBN393, 23ABJ223, 23EBK530, 23HBS351; d) REF DYNJ908877, UDI/DI 40195327201747 (case), 10195327201746 (unit), Lot Numbers: 22HBT779, 22KBH144, 22LBM695, 23ABD156; e) REF DYNJ83093, UDI/DI 40195327230870 (case), 10195327230869 (unit), Lot Numbers: 22JME508, 23CMH924, 23DMH299, 23EMC295, 23FMB041