Recalls / —

—#169055

Product

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

FDA product code

GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot Number 1816211264

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm

COVIDIEN LLC

Address

15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

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.

Timeline

Recall initiated

2018-11-05

Terminated

2020-08-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #169055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.