—#188936

Product

ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K913661
Affected lot / code info: Lot Code: 0061770206 DI: 04046964297410

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Canada.

Timeline

Recall initiated: 2021-08-10
Terminated: 2024-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188936. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.