Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Summary
The FDA issued a Class II for Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe by MEDLINE INDUSTRIES, LP - Northfield. Reason: Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential f.
Details
Source
Device Recall
External ID
Z-1157-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Lot/Code Info: UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
Quantity Affected: 4831 units
Reason for Recall
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
Distribution
US, Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-04
Company
Northfield, IL
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 257 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 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 (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1157-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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