MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDE

Hazard

Trumpet Needle Guide ring can detach when excessive pressure is applied.

Details from the source

Reason for recall: Trumpet Needle Guide ring can detach when excessive pressure is applied. Distribution: US Nationwide distribution. Quantity: 12994 units Lot/code info: 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;

UPC codes

40195327330713, 10195327330712, 40195327424047, 10195327424046, 40195327338610, 10195327338619

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.