FDAClass IIJuly 1, 2015

McKesson Medi-Pak Vaginal Speculum recall

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

Why was McKesson Medi-Pak Vaginal Speculum recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Work Order:164290

Product
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological…
Recalling firm
CooperSurgical, Inc.
Quantity
9400 units
Distribution
Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
Recall date
July 1, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls