Device product
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.
Z-2111-2018
Product summary
- Event
- Event 80093
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,400 units
- Official record key
device-enforcement:Z-2111-2018
Official wording
Reason: Reports of incorrect priming volume due to manufacturing with incorrect tubing.
Code information: Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167
Distribution pattern: US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
Derived failure modes
-
Unknown
Reports of incorrect priming volume due to manufacturing with incorrect tubing.