Z-1346-2018 Class II Terminated
FDA device recall Z-1346-2018 was initiated by ICU Medical, Inc. on Feb 5, 2018 and is designated Class II. Reason for recall: The infusion sets were manufactured with an incorrect spin collar. The recall status is terminated (terminated Sep 17, 2019). Affected quantity: 100 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Feb 5, 2018
- Termination Date
- Sep 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 pouches
Product Description
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, 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 3549002, UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1346-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026