OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT
Summary
The FDA issued a Class II for OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Sa 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-2557-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
Lot/Code Info: Lot Code: 0061769182 DI: 04046955275588
Quantity Affected: 768 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-2557-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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