Z-1425-2018 Class II Terminated
FDA device recall Z-1425-2018 was initiated by Carefusion 2200 Inc on February 23, 2017 and is designated Class II. Reason for recall: The integrity of the sterile packaging is potentially compromised. The recall status is terminated (terminated July 9, 2019). Affected quantity: 14,200 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 25, 2018
- Initiation Date
- February 23, 2017
- Termination Date
- July 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,200 units
Product Description
JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
Reason for Recall
The integrity of the sterile packaging is potentially compromised.
Distribution Pattern
Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
Code Information
Product Code: a.) TJM3513 / LOT 0000836582, 0000838949, 0000843968, 0000849685, 0000852933; b.) TJM4008 / LOT 0000841349, 0000841348, 0000843961, 0000849132, 0000852123, 0000853877; c.) TJM4011 / LOT 0000836575, 0000838950, 0000840195, 0000843075, 0000843076, 0000846708, 0000852932, 0000853878, 0000854861, 0000854983; d.) TJM6008 / LOT 0000842725, 0000853971; e.) TJM6011 / LOT 0000843077, 0000849713, 0000854659