Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set us
Summary
The FDA issued a Class II for Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartS by BD SWITZERLAND SARL. Reason: Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users t.
Details
Source
Device Recall
External ID
Z-1944-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
Product Description
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
Lot/Code Info: Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368
Quantity Affected: 11.300 sets
Reason for Recall
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
Distribution
Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-18
Company
Eysins, N/A
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 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls.
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 (BD SWITZERLAND SARL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BD SWITZERLAND SARL have FDA actions?
BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1944-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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