Z-1824-2015 Class II Terminated
FDA device recall Z-1824-2015 was initiated by CooperSurgical, Inc. on Apr 13, 2015 and is designated Class II. Reason for recall: Small sized specula were incorrectly packaged in printed bags for the medium sized speculum The recall status is terminated (terminated Feb 5, 2016). Affected quantity: 9400 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 1, 2015
- Initiation Date
- Apr 13, 2015
- Termination Date
- Feb 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9400 units
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
Distribution Pattern
Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
Code Information
Work Order:164290
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1824-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026