Z-1768-2019Class I

Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The...

Name: Z-1768-2019 Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The...
Creator: CareFusion 303, Inc.
Published: 2018-04-13
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2018-04-13 / Terminated / root cause: design

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they... on 2018-04-13. FDA classified it as Class I and gives the reason as "The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1768-2019
Classification: Class I
Status: Terminated
Initiated: 2018-04-13
Posted: 2019-07-16
Terminated: 2023-12-26
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204). Product Usage: The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. There are 6 bezel posts on the Alaris Pump bezel assembly.
Product code: FRN Pump, Infusion
Reason for recall: The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 04/20/18, the firm mailed Medical Device Recall Notification letters. Customers were advised that affected units outlined in the previous September 1, 2017 recall will now include affected devices with date codes September 2011 through December 2011. Customers were asked to remove the pump from use if there are signs of infusion at an unexpected rate. Use non-affected devices in high risk areas if possible. Consider having additional devices as back up until your affected devices are remediated. If the user experiences the issue described in this notification, clearly mark and sequester the devices from use and notify Support Center. Customers were asked to complete and return the Customer Response Cards to acknowledge receipt of the notification. Firm will contact all affected customers within 60 days to replace the mechanical assemblies on affected serial numbers at no charge. Customers experiencing the issue described in this notification are encouraged to call the Support Center at 888-562-6018 or email [email protected]. On 04/15/19 the firm mailed URGENT: Medical Device Recall Notification letters. Customers were advised that the firm will contact customers of Priority 1 pumps within 60 days of this notification to initiate scheduling of the inspection of those pumps. The firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Until the bezels affected by this recall are replaced by the firm, customers should inspect bezels of both Priority 1 and Priority 2 pumps during their annual preventative maintenance schedule. Any pumps with bezel post separation should be removed from service. The recalling firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Customers were asked to complete and return Customer Response Cards to acknowledge receipt of this notification. In addition to the Support Cente
Quantity in commerce: 607618
Distribution: Worldwide Distribution - U.S. Nationwide CA, TX, NC, AL, ID, TN, IN, MA, UT, HI, NH, PA, IL, OR, FL, MI, VA, AR, OH, GA, NY, MD, MN, NM, AZ, KY, WI, NE, MS, DC, MO, KS, SC, LA, MT, WA, NJ, CO, CT, OK, AK, AS, CU, DE, GU, IA, ME, MP, ND, NV, PR, SD, VT, WV, WY; OUS: AE, AU, BH, CA, CH, CN, GI, IL, IN, KW, MX, MY, NL, NZ, PH, PK, QA, SA, SG, TW, and ZA.
Product codes and lots: All pumps manufactured between April 2011 and June 2017, that have bezel mechanical assemblies manufactured with FR-110 plastic resin. And all pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1768-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1768-2019	Class I	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-16

Product code FRN

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

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)