FDA-Device2018-03-07Class II

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

Cook Inc.
Hazard

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

Sold states
US Nationwide Distribution
Affected count
615
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief