Brand Name: Basal/Bolus Infusor — Class II medical device recall Z-1606-2013
Terminated recall by Baxter Healthcare Corp., reported 2013-07-03, distributed nationwide. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due t
| Recall number | Z-1606-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Round Lake, IL, United States |
| Recall initiated | 2013-06-07 |
| Classified | 2013-06-27 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 3,255,096 total |
| Lot numbers | 08K006, 08M038, 08N001, 09C021, 09E028, 09F078, 09H033, 09H080, 09J046, 09M052, 09N030, 09N048, 108023, 10A043, 10B028, 10B081, 10E004, 10E054, 10H055, 10J031, 10J106, 10K050, 10M085, 10N026 |
| Expiration dates | 2015-06-30 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1606-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.