Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0656-2019

November 05, 2018

Class II

Product summary

Firm
COVIDIEN LLC
Event
Event 81607
Status
Terminated
Classification
Class II
Quantity
32,071 units
Official record key
device-enforcement:Z-0656-2019

Official wording

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

Code information: Lot Number 1816211264

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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