FDA Device recall Z-1720-2022
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer
- FDA Device
- Class II
- ongoing
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer by Icu Medical, citing due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1720-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-01 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Icu Medical |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Reason
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Identifiers
| code_info | Product Number: 12517-01 UDI Code: 0110887709047201172612013050105735675 0110887709047201172612013050105755784 0110887…Product Number: 12517-01 UDI Code: 0110887709047201172612013050105735675 0110887709047201172612013050105755784 0110887709047201172612013050105755788 0110887709047201172702013050105812525 Lot Numbers: 5735675 5755784 5755788 5812525 Product Number: A1099 UDI Codes: 0110887709053127172611013050105692378 Lot Numbers: 5692378 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: A1132 UDI Code: 0110887709068350172701013050105772482 Lot Number: 5772482 Product Number: A1152 UDI Code: 0110887709071527172612013050105735432 0110887709071527172701013050105787700 Lot Number: 5735432 5787700 Product Number: MC330113 UDI Codes: 0110887709078120172612013050105746371 0110887709078120172612013050105755711 0110887709078120172701013050105789359 Lot Numbers: 5746371 5755711 5789359 Product Number: MC330246 UDI Codes: 0110887709081502172610013050105641882 0110887709081502172612013050105738474 011088770 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1720-2022%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.