Z-1347-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- February 5, 2018
- Termination Date
- September 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,600 pouches
Product Description
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Reason for Recall
The infusion sets were manufactured with an incorrect spin collar.
Distribution Pattern
Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
Code Information
Lot number 3422861, UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861; lot number 3489493, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3489493; lot number 3498769, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498769; and lot number 3498773, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498773.