FDA Device recall Z-1345-2018
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm na…
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm na… by Icu Medical, citing the infusion sets were manufactured with an incorrect spin collar.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1345-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-05 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, 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
The infusion sets were manufactured with an incorrect spin collar.
Identifiers
| code_info | Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848; lot number 3511823, UDI (01) 0 0887709…Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848; lot number 3511823, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3511823; lot number 3516092, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3516092; and lot number 3545075, UDI (01) 0 0887709 01806 8 (17) 221001 (30) 01 (10) 3545075. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1345-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.