Device product
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
Z-1918-2024
Product summary
- Event
- Event 94448
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12994 units
- Official record key
device-enforcement:Z-1918-2024
Official wording
Reason: Trumpet Needle Guide ring can detach when excessive pressure is applied.
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;
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Trumpet Needle Guide ring can detach when excessive pressure is applied.