Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ412 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-2991-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
Lot/Code Info: DYNJ41223, Lot Number 21HBU861 ; DYNJ41223, Lot Number 21KBA848 ; DYNJ41223, Lot Number 21KBA910 ; DYNJ41223, Lot Number 22ABA546 ; DYNJ41223, Lot Number 22MBA262 ; DYNJ41223, Lot Number 19BBC903 ; DYNJ41223, Lot Number 19CBO901 ; DYNJ41223, Lot Number 19DBW422 ; DYNJ41223, Lot Number 22HBY065 ; DYNJ41223, Lot Number 19HBD957 ; DYNJ41223, Lot Number 19HBJ856 ; DYNJ41223, Lot Number 19IBT476 ; DYNJ41223, Lot Number 22KBU048 ; DYNJ41223, Lot Number 19VBD385 ; DYNJ41223, Lot Number 19LBF954 ; DYNJ41223, Lot Number 23EBC280 ; DYNJ41223, Lot Number 23FBA251 ; DYNJ41223, Lot Number 20BBP883 ; DYNJ41223, Lot Number 20CBI263 ; DYNJ41223, Lot Number 23JBC138 ; DYNJ41223, Lot Number 23KBO541 ; DYNJ41223, Lot Number 20IBJ759 ; DYNJ41223, Lot Number 20JBE058 ; DYNJ41223, Lot Number 20XBF374
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-2991-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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