Z-0756-2017 Class II Terminated
FDA device recall Z-0756-2017 was initiated by Covidien LLC on Oct 14, 2016 and is designated Class II. Reason for recall: Sterility of the outer surface of the container compromised due to packaging defect. The recall status is terminated (terminated Aug 8, 2018). Affected quantity: 5,187,100 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2016
- Initiation Date
- Oct 14, 2016
- Termination Date
- Aug 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,187,100 Units
Product Description
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
Reason for Recall
Sterility of the outer surface of the container compromised due to packaging defect.
Distribution Pattern
Nationwide Foreign: Japan
Code Information
All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0756-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026