Home / Recalls / Baxter Healthcare Corp. / Z-1606-2013

Z-1606-2013 Class II Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA device recall Z-1606-2013 was initiated by Baxter Healthcare Corp. on Jun 7, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 4, 2014). Affected quantity: 3,255,096 total.

Recall Details

Product Type: Devices
Report Date: Jul 3, 2013
Initiation Date: Jun 7, 2013
Termination Date: Jun 4, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,255,096 total

Product Description

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

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.

Distribution Pattern

Distributed Nationwide and in Puerto Rico.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1606-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Baxter Healthcare Corp.

Z-3133-2017 Class II — Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 (Sep 1, 2017)
Z-0370-2017 Class II — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code… (Oct 12, 2016)
Z-0671-2017 Class II — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum… (Sep 28, 2016)
Z-0672-2017 Class II — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA… (Sep 28, 2016)
Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum… (Sep 28, 2016)
Z-2533-2016 Class II — Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product… (Jun 24, 2016)
Z-2049-2016 Class II — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy (May 23, 2016)
Z-1838-2016 Class II — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular… (May 12, 2016)
Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular… (May 12, 2016)
Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular… (May 12, 2016)