Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPI
Summary
The FDA issued a Class II for Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.
Details
Source
Device Recall
External ID
Z-2985-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK
Lot/Code Info: DYNJ59573A , Lot Number 23IBP764 ; DYNJ59573A , Lot Number 23JBM050 ; DYNJ59573A , Lot Number 23KBM610 ; DYNJ59573A , Lot Number 24ABC779 ; DYNJ39451D , Lot Number 22BDB647 ; DYNJ39451D , Lot Number 22CDA099 ; DYNJ39451D , Lot Number 22LDA195 ; DYNJ39451D , Lot Number 23DDB501 ; DYNJ39451D , Lot Number 23DDB666 ; DYNJ39451D , Lot Number 23EDA821 ; DYNJ80281A , Lot Number 23ADA194 ; DYNJ80281A , Lot Number 23DDA881 ; DYNJ80281A , Lot Number 23HDA513 ; DYNJ80281A , Lot Number 23JDC172 ; DYNJ80281A , Lot Number 23LDB860 ; DYNJ80281A , Lot Number 24ADC258 ; DYNJ80281A , Lot Number 24CDA973
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
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-2985-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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