Z-0656-2019 Class II Terminated
FDA device recall Z-0656-2019 was initiated by COVIDIEN LLC on Nov 5, 2018 and is designated Class II. Reason for recall: The product was released into commercial distribution while subject to importation refusal. The recall status is terminated (terminated Aug 14, 2020). Affected quantity: 32,071 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Nov 5, 2018
- Termination Date
- Aug 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,071 units
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.
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.
Code Information
Lot Number 1816211264
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0656-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026