Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 18, 2013
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300E
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System w…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
B Braun Medical, Inc. recalled Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used… - a moderate-severity action.
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used… was recalled by B Braun Medical, Inc. in September 18, 2013. Reason: This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 A…. Check the official notice for the remedy. Verify recall #Z-2164-2013 with the FDA Devices before acting.
The recall
B Braun Medical, Inc. issued this moderate-severity FDA Devices recall-This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 A….
- Moderate
- severity level
- Class II
- classification
- September 18, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2164-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2164-2013) was formally reported on September 18, 2013, with the manufacturer initiating the action on October 31, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. B Braun Medical, Inc. is listed as the recalling firm, operating out of Carrollton, TX. Federal records list the affected scope as 1,970 pumps added for this expansion.
The documented reason for this recall is: This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be … Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,970 pumps added for this expansion
Related Recalls
6
3 from same agency
Product description
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
Reason for recall
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2164-2013 |
| Date reported | September 18, 2013 |
| Date initiated | October 31, 2012 |
| Recalling firm | B Braun Medical, Inc. |
| Firm location | Carrollton, TX |
| Affected scope | 1,970 pumps added for this expansion |
| Distribution | Nationwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2164-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.. Recalled by B Braun Medical, Inc.. Units affected: 1,970 pumps added for this expansion.
Why was this product recalled? ▼
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2013. Severity: Moderate. Recall number: Z-2164-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2164-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 18, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.