Device product
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
Z-1824-2015
Product summary
- Event
- Event 71313
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9400 units
- Official record key
device-enforcement:Z-1824-2015
Official wording
Reason: Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
Code information: Work Order:164290
Distribution pattern: Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
Derived failure modes
-
Unknown
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum