Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC L
Summary
The FDA issued a Class II for Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PA 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-3055-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYNJ54607A ; 3) LOCAL PACK, Pack Number DYNJ61839B
Lot/Code Info: DYNJ34129C , Lot Number 21GBT130 ; DYNJ34129C , Lot Number 21LBL623 ; DYNJ34129C , Lot Number 22ABM033 ; DYNJ34129C , Lot Number 22ABX499 ; DYNJ34129C , Lot Number 19BBD954 ; DYNJ34129C , Lot Number 19DBZ455 ; DYNJ34129C , Lot Number 19EBU077 ; DYNJ34129C , Lot Number 19GBU537 ; DYNJ34129C , Lot Number 22IBG550 ; DYNJ34129C , Lot Number 19JBN034 ; DYNJ34129C , Lot Number 20BBF056 ; DYNJ34129C , Lot Number 23FBG792 ; DYNJ34129C , Lot Number 23GBE376 ; DYNJ34129C , Lot Number 20FBS002 ; DYNJ34129C , Lot Number 23JBR570 ; DYNJ34129C , Lot Number 23JBY629 ; DYNJ34129C , Lot Number 23KBU960 ; DYNJ34129C , Lot Number 23KBW607 ; DYNJ34129C , Lot Number 20KBW597 ; DYNJ34129C , Lot Number 20LBM567 ; DYNJ34129C , Lot Number 21EBA688 ; DYNJ54607A , Lot Number 21HBS933 ; DYNJ54607A , Lot Number 21JBH960 ; DYNJ54607A , Lot Number 21JBZ002 ; DYNJ54607A , Lot Number 21LBJ925 ; DYNJ54607A , Lot Number 19BBP092 ; DYNJ54607A , Lot Number 19CBB568 ; DYNJ54607A , Lot Number 22GBH746 ; DYNJ54607A , Lot Number 22GBZ352 ; DYNJ54607A , Lot Number 19GBT320 ; DYNJ54607A , Lot Number 22IBG226 ; DYNJ54607A , Lot Number 19VBA464 ; DYNJ54607A , Lot Number 19LBN255 ; DYNJ54607A , Lot Number 23EBA098 ; DYNJ54607A , Lot Number 20DBI269 ; DYNJ54607A , Lot Number 20GBW370 ; DYNJ54607A , Lot Number 21ABE502 ; DYNJ54607A , Lot Number 21ABO952 ; DYNJ54607A , Lot Number 21ABT074 ; DYNJ61839B , Lot Number 21JBP698 ; DYNJ61839B , Lot Number 21LBL729 ; DYNJ61839B , Lot Number 22ABU420 ; DYNJ61839B , Lot Number 22EBJ226 ; DYNJ61839B , Lot Number 22HBA748 ; DYNJ61839B , Lot Number 22IBR542 ; DYNJ61839B , Lot Number 19IBN952 ; DYNJ61839B , Lot Number 19LBT615 ; DYNJ61839B , Lot Number 23EBD346 ; DYNJ61839B , Lot Number 23GBE331 ; DYNJ61839B , Lot Number 20DBD020 ; DYNJ61839B , Lot Number 20GBV525 ; DYNJ61839B , Lot Number 20JBC796 ; DYNJ61839B , Lot Number 24ABV143 ; DYNJ61839B , Lot Number 20KBZ290 ; DYNJ61839B , Lot Number 21DBR237 ; DYNJ61839B , Lot Number 21EBP718 ;
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-3055-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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