FDA-Device2024-06-05Class II
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
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Sold states
US Nationwide distribution.
Affected count
12994 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2024Don't want to check this manually?
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