RecallRadar

FDA Device recall Z-1606-2013

Brand Name: Basal/Bolus Infusor

On 2013-07-03 the FDA classified a Class II recall of Brand Name: Basal/Bolus Infusor by Baxter Healthcare, citing 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 a….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1606-2013
ClassificationClass II
Statusterminated
Initiated2013-06-07
Published2013-07-03
Last updated2026-09-13 11:53 UTC
CompanyBaxter Healthcare
DistributionUS

Product

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

Reason

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.

Identifiers

code_info
Product Codes: 2C1955KJP, 2C1976KJ Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M0…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1606-2013%22

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