Z-2628-2018 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
121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 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 B9752, Lot Number 3336049, 3351027, 3352504, 3389728, 3391951, 3412098, 3419605, 3423455