Z-0089-2018 Class II Terminated
FDA device recall Z-0089-2018 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: 263 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
- 263 units
Product Description
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
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. 12358202; Ref No. 125-2035T.