Recall Z-1566-2020— Cook Inc.

Name: FDA recall Z-1566-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-06

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2020-03-06, terminated 2020-12-18. It names one FDA 510(k) clearance: K033843. Product: Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053. Reason: The printed expiration dates are incorrect..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-06
Terminated: 2020-12-18
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K033843 — SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATINGCook, Inc.·cleared 2004-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.