Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBA
Summary
The FDA issued a Class II for Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, by MEDLINE INDUSTRIES, LP - Northfield. Reason: Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effective.
Details
Source
Device Recall
External ID
Z-1183-2025
Action Date
2025-02-26
Status
Ongoing
Category
device
Product Description
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Lot/Code Info: 1) ACC010809, UDI-DI 10198459012235 (each) 40198459012236 (case), Lot Number 24JDC400; 2) ACC010813, UDI-DI 10198459012556 (each) 40198459012557 (case), Lot Number 24KDA437
Quantity Affected: 0 kits
Reason for Recall
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Distribution
US States: CA, NY
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-09
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 167 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-1183-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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