Outlook®
Large Volume Infusion Pump System with Outbound Wireless, Drug Library and Barcoding
5manufacturers in China registered for this device type
21catalogue numbers in this listing
11510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2024-04-02 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Fragile, handle with care |
| Distribution end date | 2024-03-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 621-124ES | In distribution | ||
| 477009 | 24 | In distribution | |
| 490564 | 24 | In distribution | |
| 621-324ES | In distribution | ||
| 621-224ES | In distribution | ||
| 621-100ES | Withdrawn | ||
| 621-200ESR | Withdrawn | ||
| 621-200ES | Withdrawn | ||
| 621-123ES | Withdrawn | ||
| 621-100ESR | Withdrawn | ||
| 621-122ES | Withdrawn | ||
| 621-100ES99 | Withdrawn | ||
| 620-100R | Withdrawn | ||
| 621-200ES99 | Withdrawn | ||
| 621-300ESR | Withdrawn | ||
| FZ00621HHS | Withdrawn | ||
| 621-400ES | Withdrawn | ||
| FZ000621NC | Withdrawn | ||
| 621-400ESR | Withdrawn | ||
| 621-223ES | Withdrawn | ||
| 621-300ES | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
| Plum | ICU Medical, Inc | 14 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172831 | 2018-06-12 |
| K142596 | 2015-06-18 |
| K083689 | 2009-07-01 |
| K062700 | 2006-10-26 |
| K062699 | 2006-10-26 |
| K023189 | 2003-03-20 |
| K022575 | 2002-08-21 |
| K011975 | 2001-09-19 |
| K003029 | 2000-12-04 |
| K994375 | 2000-03-08 |
| K983005 | 1999-02-04 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | UDI-DI | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 2,352 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 2352 units |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-08-07 | Class I | Component design/selection | Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Addit | 14 | |
| 2024-06-14 | Class II | Device Design | Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, an | 9943 | |
| 2024-06-14 | Class II | Device Design | Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, an | 4519 | |
| 2024-06-14 | Class II | Device Design | Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, an | 14949 | |
| 2024-06-14 | Class II | Device Design | Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, an | 930 | |
| 2024-06-14 | Class II | Device Design | Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, an | 1663 | |
| 2012-12-05 | Class II | Component design/selection | B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) | 14,161 | 2014-10-24 |
| 2012-11-14 | Class I | Software design | This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the “RUN” Light Emitting Diodes (L | 6,919 | 2015-03-06 |
| 2012-10-31 | Class II | Software design | 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 removi | 1,970 pumps added for this expansion | 2016-02-03 |
| 2012-10-24 | Class II | Component design/selection | B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to | 28,427 | 2015-07-27 |
| 2011-09-07 | Not classified | Software design | B Braun Outlook ES Safety Infusion System “Run” Light Emitting Diodes (LEDs) pumps stop infusing and a backup alarm sounds, but the “Run” LEDs advance as if the pumps were infusing. | 6321 | 2015-05-04 |
| 2010-08-24 | Not classified | Component design/selection | Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operati | 2,107 Pumps (582 Pumps to Winchester) | 2014-05-29 |
| 2010-07-20 | Not classified | Software design | The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel. | 11,525 pumps | 2015-01-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.