Z-0087-2018 Class II Terminated
FDA device recall Z-0087-2018 was initiated by Epimed International on July 24, 2017 and is designated Class II. Reason for recall: Potential for partially incomplete seal of product, impacting sterility. The recall status is terminated (terminated July 6, 2023). Affected quantity: 500 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- July 24, 2017
- Termination Date
- July 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 units
Product Description
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Reason for Recall
Potential for partially incomplete seal of product, impacting sterility.
Distribution Pattern
Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
Code Information
Lot No. 12168200; Ref No. 107-1416.