Medical device recalls Moderate risk

CooperSurgical, Inc. recalls McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visu…

Recall date
April 13, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1824-2015
FDA classification
Class II
Brand / firm
CooperSurgical, Inc.
Sold / distributed
Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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