FDA-Device2022-04-06Class II
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.
Carefusion 2200 Inc
Hazard
The finished device package did not contain the IFU.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, IN, LA, MA, MI, MN, MS, MT, NC, NY, OH, OK, PA, TN, TX, VA, and WI. The countries of Taiwan and Australia.
Affected count
152 units
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0833-2022Don't want to check this manually?
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