FDA Device recall Z-0186-2021
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer by Icu Medical, citing identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoCl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0186-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-06 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)50(10)4572718; (01)10887709051048(17)250101(30)50(10)4603246; (01)10887709051048(17)250201(30)50(10)4718507; (01)10887709051048(17)241201(30)50(10)4537122; (01)10887709051048(17)241201(30)50(10)4549054; (01)10887709051048(17)250201(30)50(10)4734370. 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
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Identifiers
| code_info | Lot Numbers: 4572718,4603246, 4718507,4537122, 4549054 4734370. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0186-2021%22
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