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
FDA Recall Z-1824-2015 · Posted 2015-06-22
Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHIB
Date Initiated2015-04-13
Date Terminated2016-02-05
Product Quantity9400 units
Reason for Recall
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
Firm Action
CooperSurgical sent an Urget Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to discontinue use, discard, or return the affected to product to Cooper Surgical. Customers were asked to complete the attached Acknowledgment and Receipt Form for replacement. Customers with questions were instructed to call 203-601-5200.
Root Cause
Packaging change control
Distribution Pattern
Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.