Z-2648-2018 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
143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, 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 Z2819, Lot Number 69-338-SJ, 72-415-HE