Z-2533-2017 Class II Terminated
FDA device recall Z-2533-2017 was initiated by Applied Medical Resources Corp on May 4, 2017 and is designated Class II. Reason for recall: Due to possibility of insufficient sterilization. The recall status is terminated (terminated March 6, 2018). Affected quantity: 7,939 units total (870 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 4, 2017
- Termination Date
- March 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,939 units total (870 units in US)
Product Description
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Reason for Recall
Due to possibility of insufficient sterilization.
Distribution Pattern
US and worldwide: Australia, Finland, France, United Kingdom
Code Information
CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)