Z-2559-2021Class II

Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with...

Name: Z-2559-2021 Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with...
Creator: B. Braun Medical, Inc.
Published: 2021-08-10
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2021-08-10 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon... on 2021-08-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2559-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-10
Posted: 2021-09-24
Terminated: 2024-09-16
Recalling firm: B Braun Medical Inc
Product: Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
Product code: FPA Set, Administration, Intravascular
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 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 [email protected] 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: 1,080 units
Distribution: Worldwide distribution - US Nationwide distribution and the country of Canada.
Product codes and lots: Lot Code: 0061770205 DI: 04046964189388

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2559-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2544-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2545-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2546-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2547-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2548-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2549-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2550-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2551-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2552-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2553-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2554-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2555-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2556-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2557-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2558-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2559-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2560-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)