FDA recall Z-2281-2019

Canadian Hospital Specialties · Class II · device

Product

MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R

Reason for recall

The firm received a complaint that the connector detached from the feeding tube.

Distribution

GA and TN

Key facts

Status
Terminated
Initiation date
2019-07-16
Report date
2019-08-21
Termination date
2025-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakville, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2281-2019