FDA recall Z-1566-2020

Cook Inc. · Class II · device

Product

Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053

Reason for recall

The printed expiration dates are incorrect.

Distribution

The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.

Key facts

Status
Terminated
Initiation date
2020-03-06
Report date
2020-04-01
Termination date
2020-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1566-2020