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Terminated

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

FDA Recall Z-0656-2019 · Posted None

Recalling FirmCOVIDIEN LLC
Recall StatusTerminated
Product CodeGCY
Date Initiated2018-11-05
Date Terminated2020-08-14
Product Quantity32,071 units

Reason for Recall

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

Firm Action

Urgent Medical Device Recall letters dated 11/5/18 were sent to customers.

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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