PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 1, 2015 Initiated: April 13, 2015 #Z-1824-2015

Product Description

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

Reason for Recall

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

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
9400 units
Distribution
Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
Location
Trumbull, CT

Frequently Asked Questions

What product 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. Recalled by CooperSurgical, Inc.. Units affected: 9400 units.
Why was this product recalled?
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
Which agency issued this recall?
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1824-2015.