Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ 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-3025-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B
Lot/Code Info: DYNJ0281516M , Lot Number 19EBW985 ; DYNJ0281516M , Lot Number 19FBS033 ; DYNJ0281516M , Lot Number 19GBE356 ; DYNJ0281516M , Lot Number 19GBN481 ; DYNJ0281516M , Lot Number 19SBC273 ; DYNJ0281516M , Lot Number 19VBH540 ; DYNJ0281516M , Lot Number 19LBS319 ; DYNJ0281516M , Lot Number 20ABZ597 ; DYNJ0281516M , Lot Number 20DBH983 ; DYNJ0281516M , Lot Number 20FBJ183 ; DYNJ0281516M , Lot Number 20HBK308 ; DYNJ0281516M , Lot Number 20JBZ789 ; DYNJ0281516M , Lot Number 20LBU288 ; DYNJ0281516M , Lot Number 21CBD769 ; DYNJ0281516M , Lot Number 21EMF053 ; DYNJ0281516M , Lot Number 21GMB207 ; DYNJ0281516M , Lot Number 21HMD725 ; DYNJ0281516M , Lot Number 21IMF128 ; DYNJ0281516M , Lot Number 21LMC143 ; DYNJ0281516M , Lot Number 22AMF940 ; DYNJ0281516M , Lot Number 22CMC800 ; DYNJ0281516M , Lot Number 22CMD981 ; DYNJ0281516M , Lot Number 22EMG839 ; DYNJ0281516M , Lot Number 22EMH435 ; DYNJ0281516M , Lot Number 22HMC805 ; DYNJ0281516M , Lot Number 22JMA630 ; DYNJ0281516M , Lot Number 22LMA629 ; DYNJ0281516M , Lot Number 23AMB717 ; DYNJ0281516M , Lot Number 23BMI443 ; DYNJ0281516M , Lot Number 23DMG317 ; DYNJ0281516M , Lot Number 23FMC971 ; DYNJ0281516M , Lot Number 23GMD118 ; DYNJ0281516M , Lot Number 23HMH453 ; DYNJ0281516M , Lot Number 23JMB170 ; DYNJ0281516M , Lot Number 23KME384 ; DYNJ0281516M , Lot Number 19AKA641 ; DYNJ0281516M , Lot Number 19BKD684 ; DYNJ0281516M , Lot Number 19DKC345 ; DYNJ0484979B , Lot Number 18LBO447 ; DYNJ0484979B , Lot Number 19CBU327
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-3025-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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