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U.S. Department of Health and Human Services

Class 2 Device Recall Outlook Pump Sets

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  Class 2 Device Recall Outlook Pump Sets see related information
Date Initiated by Firm August 10, 2021
Create Date September 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-2544-2021
Recall Event ID 88531
510(K)Number K083723  K913661  
Product Classification Set, administration, intravascular - Product Code FPA
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
Code Information 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
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact SAME
610-596-0500
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 978,876 units
Distribution Worldwide distribution - US Nationwide distribution and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = FPA and Original Applicant = MCGAW, INC.
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