B. Braun Medical, Inc.: 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212

Recall number

Z-2544-2021

Recalling firm

B. Braun Medical, Inc.

Product

15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212

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

978,876 units

Distribution

Worldwide distribution - US Nationwide distribution and the country of Canada.

Lot, serial or model codes

Lot Code: 0061752459 0061752460 0061755100 0061755637 0061757837 0061757838 0061758588 0061759428 0061759475 0061761605 0061765911 0061766189 0061767026 0061767841 0061769047 0061769091 0061769931 0061770185 0061770486 0061771274 0061772190 0061775452 0061776078 0061776101 0061776773 0061776915 0061777160 0061777161 0061780362 Lot Codes: 0061780840 0061781779 00VL752554 DI: 04046964293832

510(k) numbers

["K083723","K913661"]

PMA numbers

not on file

Product code

FPA

Firm FEI

2523676

Firm city

Allentown

Firm state

PA

Firm country

not on file

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

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