FDA-Device2015-07-01Class II

McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

CooperSurgical, Inc.
Hazard

Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

Sold states
Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
Affected count
9400 units
Manufactured in
75 Corporate Dr, Trumbull, CT, United States
Products
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2015

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