PlainRecalls
FDA Devices Moderate Class II Terminated

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

Reported: December 26, 2018 Initiated: November 5, 2018 #Z-0656-2019

Product Description

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

Reason for Recall

The product was released into commercial distribution while subject to importation refusal.

Details

Recalling Firm
COVIDIEN LLC
Units Affected
32,071 units
Distribution
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826. Recalled by COVIDIEN LLC. Units affected: 32,071 units.
Why was this product recalled?
The product was released into commercial distribution while subject to importation refusal.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0656-2019.