Z-2649-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2018
- Initiation Date
- July 31, 2017
- Termination Date
- March 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160,016 units total
Product Description
159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Reason for Recall
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Distribution Pattern
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
Code Information
Item Number Z2902, Lot Number 69-365-SJ, 69-707-SJ, 70-196-SL, 70-400-SL, 70-759-SL, 70-918-SL, 70-952-SJ, 71-189-Y1, 71-562-Y1, 71-669-Y1, 71-861-Y1, 73-604-HE, 73-877-HE, 74-014-JW, 74-320-JW, 74-463-JW, 74-733-JW, 75-262-JW, 75-420-JW, 75-644-JW, 75-846-JW, 76-096-SJ