REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
Reported: May 13, 2020 Initiated: October 4, 2019 #Z-1917-2020
Product Description
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
Reason for Recall
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 4800 units
- Distribution
- US:AK,AL,AR,AZ,CA,CO,CT,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,SD,TN,TX,UT,VA,WA,WI,WY OUS: Canada *** "REF" numbers AH7117 and B30211 were not marketed or distributed within the US***
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074. Recalled by ICU Medical, Inc.. Units affected: 4800 units.
Why was this product recalled? ▼
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1917-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11