Recall Z-1918-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1918-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-01

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-03-01. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Trumpet Needle Guide ring can detach when excessive pressure is applied..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-03-01
Firm location: Northfield, IL, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.