FDA recall Z-0830-2018

Cook Inc. · Class II · device

Product

Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Reason for recall

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2017-10-19
Report date
2018-03-07
Termination date
2019-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0830-2018