FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
- Recall number
- Z-2547-2021
- Recalling firm
- B. Braun Medical, Inc.
- Product
- 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
- Status
- Terminated
- Initiated
- 2021-08-10
- Posted
- not on file
- Terminated
- 2024-09-16
- Reason
- Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Root cause
- Under Investigation by firm
- Action
- BBraun issued Urgent Medical Device Correction letter to direct end customers and BBMI distributors, dated 8/10/21. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the impacted product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the customer level. 2. Copies of Attachment 02 should be distributed to all personnel and staff who utilize Outlook Pump Sets within their care area to ensure they identify impacted units prior to use. DO NOT use any Impacted units identified by the Instructions. Discard any Identified products to ptevent Inadvertent use. 3. B. Braun does not recommend return of this material at this time as it may lead to shortages of supply which may adversely impact patients. Not all pump sets within the identified lot are impacted. If your facility has both impacted and non-impacted lots of material, you may wish to direct impacted lots to care areas where less critical medications are administered or where risks of exposure to hazardous (e.g. cytotoxic) medications may be decreased. 4. Complete the attached "Product Correction Acknowledgement," form and return it to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt. 5. To receive credit for any units which you have had to discard via this process, please contact customer support by calling 1-800-227-2862. Please be sure to identify your local distributor when contacting customer support so we can ensure that proper credit is provided
- Quantity
- 1,960 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Lot, serial or model codes
- Lot Code: 0061758630 0061763934 DI: 04046964182259
- 510(k) numbers
- ["K083723","K781744","K913661"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28