Z-1915-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- October 4, 2019
- Termination Date
- December 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 675 units
Product Description
REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
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.
Distribution Pattern
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***
Code Information
Lot number: 4168883