FDA’s recall database lists four recall events for the Enteralite Infinity family, all Class II and all terminated: a 2008 software correction for delivery accuracy (Z-2112-2009 for the Infinity and Z-2113-2009 for the Infinity Orange), a 2012 operator’s manual addendum on infinite dose mode and air-in-line detection (Z-0764-2013), a 2012 recall of a limited set of Infinity and Infinity Orange serial numbers for circuit-board diodes that could cause an error 13 shutdown (Z-0294-2013), and a 2015 recall of ENFit delivery sets, not pumps (Z-0415-2016). We found no Class I recalls for the pump. Moog Medical, part of Moog Inc., which acquired the original maker ZEVEX in 2007, still makes and supports the pump.
The Infinity has a short recall history, and every FDA record for it has been closed for years. That is good news, but it does not mean there is nothing to check. Older pumps in the field may fall in a corrected serial range, and the current manual carries cautions that grew out of these notices. This guide puts the record in one place, in plain English, so your team can tell what applies to the pumps you have.
Who Makes the Enteralite Infinity
The pump was developed and sold by ZEVEX of Salt Lake City as the EnteraLite Infinity. Moog Inc. completed its acquisition of ZEVEX International in March 2007, and the FDA recall records show the recalling firm changing from Zevex International to MOOG Medical Devices Group by 2012. Today Moog Medical, still at 4314 Zevex Park Lane in Salt Lake City, publishes the manuals under the Infinity name and markets two models: the standard Infinity Enteral Feeding Pump (the Blue model, kit INFKIT2) and the Infinity Orange small-volume pump (listed in FDA’s recall records as INFORNG). The 2008 FDA record lists an earlier reference number, INFP01, for the original EnteraLite Infinity. FDA’s recall records list the same 510(k) clearance, K031199, for both models.
How to Check Serial Number and Software Revision
- Press and hold ON/OFF for 1.5 seconds and watch the self-test.
- Note the nine-digit serial number, which the pump shows three digits at a time. It is also printed on the serial number label on the back of the pump.
- Note the software revision that follows: the letter R and a number on the standard Infinity, or the letter N and a number on the Infinity Orange.
- Confirm all display segments light during the 2-second segment test.
- Record the model, serial number and software revision for each pump in your asset system, and compare serial numbers with the ranges below.
Moog does not publish a public list of Infinity software revisions, so we cannot tell you which revision is current. If you need to confirm a revision, contact Moog Medical or contact us and we will tell you what we can confirm.
FDA Recalls for the Infinity and Infinity Orange
All of these are Class II recalls, and all have been terminated.
| Initiated | FDA recall number | Product | Issue | Remedy |
|---|---|---|---|---|
| December 2008 | Z-2112-2009 and Z-2113-2009 | EnteraLite Infinity (REF INFP01), serial numbers 506297001–508290050; Infinity Orange (REF INFORNG), serial numbers 607129001–608275026 | Pumps may not deliver fluid accurately, potentially under-infusing or over-infusing. FDA cause: software design. | Urgent Medical Device Correction letter; customers contacted ZEVEX to schedule an upgrade of installed pumps. Terminated October 2011. |
| October 2012 | Z-0764-2013 | Infinity EnteraLite pumps, list number INFKIT2 (a long list of serial numbers) | Operator’s manual addendum on the Infinite Dose mode and the pump’s inability to detect air in line. | Urgent Field Safety Notice with an addendum to store with the manual and share with pump users. Terminated April 2014. |
| November 2012 | Z-0294-2013 | EnteraLite Infinity (INFKIT2) and Infinity Orange (INFORNG), a limited set of serial numbers | Certain diodes on the circuit board could cause insufficient voltage to part of the pump, an error 13 message and a full shutdown. FDA cause: component design or selection. | Urgent Medical Device Recall letter; customers were directed to Moog to arrange replacement pumps. Terminated January 2014. |
| November 2015 | Z-0415-2016 | EnteraLite Infinity delivery sets INF0020-A, INF0500-A and INF1200-A, plus the GR1200-A gravity feeding set, all with ENFit connector and transitional stepped connector | Possible leaking between the purple ENFit connector and the white transitional stepped connector because the purple connector could crack or break. This involved sets, not pumps. | Urgent Field Safety Notice; Moog said it would stop producing these ENFit sets and return to the earlier non-ENFit versions (INF0020, INF0500, INF1200 and GR1200) until a solution was found. Terminated August 2016. |
We searched FDA’s recall database by product name and by recalling firm (ZEVEX and Moog). Other Moog and ZEVEX recalls in that database involve Curlin infusion pumps and their administration sets, not the Infinity, so we have left them out.
What Each Recall Means Today
2008 accuracy software correction
This was a correction, not a removal: customers were told to contact ZEVEX to schedule a software upgrade for pumps in the listed serial ranges, because those pumps could under-infuse or over-infuse. If you have a pump in either range with no record of the upgrade, contact Moog Medical with the serial number and software revision to confirm the correction was applied. A delivery accuracy test is still worthwhile, but it does not confirm the software correction.
2012 infinite dose and air-in-line addendum
FDA describes the addendum as pertaining to the Infinite Dose mode and the inability of the pump to detect air in line. The current Operator’s Manual carries related cautions: when an infinite dose is used, monitor delivery and add food before the bag runs dry; the Infinite Dose and Interval Feeding options should not be used for patients who are seriously health compromised or very sensitive to air in the stomach; and sticky solids from homemade blenderized foods can obstruct the optical air sensor. Make sure caregivers have the current manual.
2012 error 13 diode recall
Customers with affected serial numbers were directed to Moog for replacement pumps, so check any older pump before keeping it in service. Health Canada’s listing describes the affected pumps as built between August 16, 2010 and April 15, 2011, but FDA’s U.S. serial list for this recall also includes some older serial numbers. Check each pump’s serial number against the full list on FDA’s Z-0294-2013 record (linked in Sources) rather than relying on build date. If an Infinity shows an error 13, turn it off and on as the manual directs, and if the error returns, remove it from service.
2015 ENFit delivery set recall
This involved the -A versions of the ENFit sets with a transitional stepped connector, not the pump. Current Infinity sets carry the -E suffix (INF0500-E, INF1200-E, INF0020-E). Check any old set stock for the -A catalog numbers listed above.
Safety Cautions in the Current Manual
Beyond the recalls, Moog’s current Operator’s Manuals (Infinity LS-25356-001 Rev. T and Infinity Orange LS-28945-001 Rev. J) include warnings that biomed and clinical teams should build into training:
- Use only Infinity brand disposable sets (the manuals’ warning). Moog’s brochure adds that Infinity Orange sets cannot be used on the standard Infinity.
- Replace bag sets every 24 hours and spike sets every 48 hours (maximum 1.5 L) to keep delivery accurate and air and occlusion sensing reliable.
- After any ER01 – ER99 alarm, check all settings and volume counters before starting a feeding.
- Do not use homemade blenderized or liquidized foods; commercially available blenderized formula can affect accuracy and performance.
- Keep tubing and cords away from infants, children and others at risk of line entanglement.
- Never clean the pump with the charger plugged into an outlet or with the pump on, and make sure the charger is dry before plugging it in.
- On the Infinity Orange, confirm rate, dose and food type before every feeding; food type resets to formula when the pump is turned off and on.
What to Do Now: A Checklist for Biomed and HTM Teams
- Record the model, serial number and software revision of every Infinity and Infinity Orange in your fleet.
- Compare serial numbers with the 2008 ranges above; for any pump in those ranges without a record of the ZEVEX software upgrade, contact Moog Medical with the serial number and software revision.
- Check serial numbers against the full list on FDA’s Z-0294-2013 record; for any match, contact Moog Medical.
- Confirm every pump has the current Operator’s Manual for its model, and that caregivers know the infinite dose and blenderized food cautions.
- Check set stock for the recalled -A ENFit set catalog numbers and keep Orange sets away from standard Infinity pumps.
- Check FDA’s recall database and Moog Medical’s website for anything newer than this guide.
How IPR Medical Can Help
Serial and history review
Send us your serial numbers and we will check them against the published FDA serial ranges we can confirm.
In-house repair and testing
We repair Infinity pumps and test them to the manufacturer’s specifications in-house at our ISO 9001:2015-certified facility in Tustin, California.
Doors, boards and batteries
We repair the physical and electronic problems we see most on the Infinity: doors and hinges, cases, batteries, main boards and motors.
Free evaluation and shipping label
U.S. customers get a free inbound label and a free evaluation. Request a free label.
Need pumps instead? Shop new and recertified (refurbished) Enteralite Infinity Blue and recertified Infinity Orange pumps, find documents in our Enteralite Infinity manuals guide and Manuals & Documentation Library, or read what we find on the bench in our Enteralite Infinity common problems guide. For repairs, see our Moog pump repair service.
Enteralite Infinity Recall FAQ
Is the Enteralite Infinity recalled?
There is no open FDA recall for the pump. FDA’s database lists three Class II recall events for the Infinity and Infinity Orange pumps, in 2008 and 2012, and one in 2015 for ENFit delivery sets. All were terminated between 2011 and 2016.
Has the Infinity enteral pump had a Class I recall?
We found no Class I recall for the Infinity or Infinity Orange pump in FDA’s recall database. All of the recalls listed for the pump family are Class II.
What was the 2012 Infinity error 13 recall?
In November 2012 (FDA recall number Z-0294-2013), Moog recalled a limited set of Infinity and Infinity Orange serial numbers because certain circuit-board diodes could cause insufficient voltage, an error 13 message and a full pump shutdown. Customers were directed to Moog to arrange replacement pumps.
Who makes the Enteralite Infinity now?
Moog Medical, part of Moog Inc., makes the pump and publishes its manuals under the Infinity name. Moog acquired the original maker, ZEVEX, in 2007.
How do I check the software revision on an Infinity pump?
Turn the pump on. After the nine-digit serial number, the display shows the software revision: the letter R and a number on the standard Infinity, or N and a number on the Infinity Orange.
Were Infinity feeding sets recalled?
Yes. In November 2015 (Z-0415-2016), Moog recalled EnteraLite Infinity ENFit delivery sets INF0020-A, INF0500-A and INF1200-A, and the GR1200-A gravity set, all with a transitional stepped connector, because the purple ENFit connector could crack and leak. The recall was terminated in August 2016.
Does IPR Medical check Infinity pumps against recall notices?
Yes. Send us serial numbers or send the pumps in for a free evaluation, and we will check them against the published FDA serial ranges we can confirm. Contact us about your fleet.
Sources
- FDA recall database: Z-2112-2009 (EnteraLite Infinity, December 2008)
- FDA recall database: Z-2113-2009 (Infinity Orange, December 2008)
- FDA recall database: Z-0764-2013 (manual addendum, October 2012)
- FDA recall database: Z-0294-2013 (error 13 diodes, November 2012)
- FDA recall database: Z-0415-2016 (ENFit delivery sets, November 2015)
- Health Canada: Enteralite and Infinity Orange pumps (archived recall listing)
- Moog Inc. press release: Moog completes acquisition of ZEVEX (March 2007)
- Moog Medical: Infinity and Infinity Orange manuals and guides
Not Sure Which of Your Pumps Are Affected?
Send us the serial numbers, or send the pumps in for a free evaluation. We will check them against the published notices and tell you what we can confirm; for notices tied to specific serial lists, the manufacturer can confirm which units were affected.
Moog, Infinity, Infinity Orange, EnteraLite, ZEVEX and ENFit are trademarks of their respective owners (Infinity is a registered trademark of Zevex, Inc.; Moog is a registered trademark of Moog Inc.; ENFit is a registered trademark of GEDSA) and are used here only to identify the original manufacturer’s equipment and products. IPR Medical is an ISO 9001:2015-certified independent service organization and is not sponsored by, affiliated with, or endorsed by the original equipment manufacturer. All other product names and trademarks are the property of their respective owners and are used only to identify those owners’ products; IPR Medical is not sponsored by, affiliated with, or endorsed by any of these trademark owners. This guide summarizes public FDA, Health Canada and manufacturer information for convenience; it is not a substitute for the manufacturer’s notices. Always follow the most current instructions from the manufacturer and FDA.