Z-1918-2024 Class II Ongoing
FDA device recall Z-1918-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 1, 2024 and is designated Class II. Reason for recall: Trumpet Needle Guide ring can detach when excessive pressure is applied. The recall status is ongoing. Affected quantity: 12994 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 5, 2024
- Initiation Date
- Mar 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12994 units
Product Description
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray
Reason for Recall
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Distribution Pattern
US Nationwide distribution.
Code Information
a) DYNDH1832: UDI/DI 40195327330713 (case), 10195327330712 (unit), Lot Numbers: 23KBI682, 23KBT359, 23KBX629; b) DYNJRA2210: UDI/DI 40195327424047 (case), 10195327424046 (unit), Lot Numbers: 23JBX245, 23LBN930; c) DYNJRA9046: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23JBX368, 23JBX369, 23JBX370, 23LBA896, 23LBH751, 23LBL612, 23LBV325, 23LBV326; d) DYNJRA9046H: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23LBL612, 23LBV325;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1918-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026