Z-2111-2018Class II

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications...

Name: Z-2111-2018 Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications...
Creator: CareFusion 303, Inc.
Published: 2017-11-06
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2017-11-06 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of 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... on 2017-11-06. FDA classified it as Class II and gives the reason as "Reports of incorrect priming volume due to manufacturing with incorrect tubing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2111-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-06
Posted: 2018-06-07
Terminated: 2020-12-07
Recalling firm: CareFusion 303, Inc
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Reports of incorrect priming volume due to manufacturing with incorrect tubing.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm, BD, sent an "URGENT: Medical Device Recall Notification" letter dated November 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately Discontinue use of the Alaris Extension Sets model 20022 lot numbers 16087775 and 16127995, and model number 30914 lot number 16127518. Contact BD for a replacement lot.; return the product for replacement using the following instructions; and immediately complete and return to BD the enclosed, pre-addressed and postage paid, Recall Response Card to: BD Support Center,10020 Pacific Mesa Blvd, San Diego CA 92121, by FAX: 1-858-617-4851 or by EMAIL: [email protected]. Note on the card your distributors name and quantities that will be returned. " Once BD receives the Recall Response Card, the BD Support Center will provide instructions for return of the affected lot numbers and replacement of the affected lots. " " All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods processed through their distributor if the products were purchased through a distributor. " " Your distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the BD Support Center at the number listed below." A second letter was sent on May 2018 adding an additional lot # for Alaris Extension Set with microbore tubing Model number 30914 lot number 17097167 Recall Related Questions BD Support Center Phone: 1-888-562-6018 Hours: 7am to 4pm PST, Monday -Friday Email: [email protected]
Quantity in commerce: 25,400 units
Distribution: US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
Product codes and lots: Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2111-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2111-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)