Z-0124-2018 Class II Terminated
FDA device recall Z-0124-2018 was initiated by Halyard Health, Inc on October 6, 2017 and is designated Class II. Reason for recall: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. The recall status is terminated (terminated September 1, 2020). Affected quantity: 52,660 kits (2,633 cases) with 631,920 saline vials.
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- October 6, 2017
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,660 kits (2,633 cases) with 631,920 saline vials
Product Description
Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
Reason for Recall
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
Distribution Pattern
Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
Code Information
Product Code 220123568 with Lot AB6151U08, AB6207U13