FDA recall Z-1918-2024

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 for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-03-01

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2024