Z-1606-2013Class II

Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications

Name: Z-1606-2013 Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications
Creator: Baxter Healthcare Corp.
Published: 2013-06-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-06-07 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications on 2013-06-07. FDA classified it as Class II and gives the reason as "Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have...". 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-1606-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-06-27
Terminated: 2014-06-04
Recalling firm: Baxter Healthcare Corporation
Product: Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Product code: FRN Pump, Infusion
Reason for recall: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.
Quantity in commerce: 3,255,096 total
Distribution: Distributed Nationwide and in Puerto Rico.
Product codes and lots: Product Codes: 2C1955KJP, 2C1976KJ Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M052 09N030 09N048 10A043 108023 10E054 10H055 10J031 10K050 10M085 10N026 09H033 10B028 10B081 10E004 10J106 Expiration Dates: 06/30/15, 12/31/14, 12/31/15, 06/30/14, 12/31/14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1606-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1600-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1601-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1602-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1603-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1604-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1605-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1606-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27

Product code FRN

K884505Class IIBasal/bolus InfusorsBaxter Healthcare Corp / cleared 1989-07-14

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)