Device recall: Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
Class II FDA enforcement event 65365. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Baxter Healthcare Corp. started this device recall on 7 Jun 2013. The firm address in the FDA record is in Round Lake, IL. FDA put the recall in Class II. FDA event 65365 has 7 product records. The first FDA enforcement report date is 3 Jul 2013. The record gives the status Terminated, with the termination date 4 Jun 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed Nationwide and in Puerto Rico.
Recalling firm
Baxter Healthcare Corp., Round Lake, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1600-2013 | Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications. | 3,255,096 total | Class II | Terminated | 3 Jul 2013 |
| Z-1601-2013 | Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications. | 3,255,096 total | Class II | Terminated | 3 Jul 2013 |
| Z-1602-2013 | Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications. | 3,255,096 total | Class II | Terminated | 3 Jul 2013 |
| Z-1603-2013 | Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. | 3,255,096 total | Class II | Terminated | 3 Jul 2013 |
| Z-1604-2013 | Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. | 3,255,096 total | Class II | Terminated | 3 Jul 2013 |
| Z-1605-2013 | Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications. | 3,255,096 total | Class II | Terminated | 3 Jul 2013 |
| Z-1606-2013 | Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications. | 3,255,096 total | Class II | Terminated | 3 Jul 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 7Median of the firm: 1
- Events of the firm on the register
- 83
Other events of the firm
Official channels
- FDA enforcement report Z-1600-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 65365. https://recallregister.com/fda/ii/65365/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed Nationwide and in Puerto Rico.
- What quantity of product is in FDA event 65365?
- The event has 7 product records. The first record gives this quantity:
3,255,096 total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.