Z-2640-2018 Class II Terminated
FDA device recall Z-2640-2018 was initiated by ICU Medical, Inc. on July 31, 2017 and is designated Class II. Reason for recall: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. The recall status is terminated (terminated March 12, 2019). Affected quantity: 160,016 units total.
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
112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 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 Z1440, Lot Number 69-334-SJ, 70-212-SL, 70-913-SL, 70-937-SJ, 71-660-Y1, 72-392-HE, 72-620-HE, 72-905-HE, 73-158-HE, 73-389-HE, 73-625-HE, 73-995-HE, 74-006-JW, 74-307-JW, 74-453-JW, 74-714-JW, 75-430-JW, 75-656-JW, 75-834-JW