V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infu
Summary
The FDA issued a Class II for V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion by B. Braun Medical, Inc.. Reason: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incompl.
Details
Source
Device Recall
External ID
Z-2551-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
Lot/Code Info: Lot Code: 0061756809 0061763935 0061768485 0061777803 DI: 04046964297434
Quantity Affected: 12,000 units
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.
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-10
Company
Allentown, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B. Braun Medical, Inc. has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B. Braun Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B. Braun Medical, Inc. have FDA actions?
B. Braun Medical, Inc. has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2551-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29