Z-2111-2018 Class II Terminated
FDA device recall Z-2111-2018 was initiated by CareFusion 303, Inc. on November 6, 2017 and is designated Class II. Reason for recall: Reports of incorrect priming volume due to manufacturing with incorrect tubing. The recall status is terminated (terminated December 7, 2020). Affected quantity: 25,400 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- November 6, 2017
- Termination Date
- December 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,400 units
Product Description
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.
Reason for Recall
Reports of incorrect priming volume due to manufacturing with incorrect tubing.
Distribution Pattern
US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
Code Information
Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167