162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, 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.
Enforcement
- Recall Number
- Z-2638-2018
- Event ID
- 80427
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- ICU Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 15, 2018
- Initiation Date
- July 31, 2017
- Classification Date
- August 7, 2018
- Termination Date
- March 12, 2019
- Address
- 951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States
Description
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, 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.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Item Number Z1278, Lot Number 70-577-SL, 70-753-SL, 71-103-Y1, 71-193-Y1, 71-536-Y1, 71-704-Y1, 71-989-Y1, 72-409-HE, 72-538-HE, 72-555-HE, 72-928-HE, 73-176-HE, 73-393-HE, 73-623-HE, 73-871-HE, 74-613-JW, 74-713-JW, 75-088-JW
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.
160,016 units total