Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number C
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 14 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-3015-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Number DYNJ66416; 6) DRAINAGE TRAY , Pack Number DYNJ68767; 7) INCISION AND DRAINAGE TRAY, Pack Number P737057
Lot/Code Info: 146255, Lot Number 23KBP730; 146255, Lot Number 23JBV770; 146255, Lot Number 23BBJ516; 146255, Lot Number 23ABS205; 146255, Lot Number 22LBQ260; 146255, Lot Number 22LBF150; CVI5080, Lot Number 24ABR654 ; CVI5080, Lot Number 24ABS414 ; DYNDA1063, Lot Number 21JBR507 ; DYNJ44599I , Lot Number 21FBO112 ; DYNJ44599I , Lot Number 21GBQ754 ; DYNJ44599I , Lot Number 21HBU200 ; DYNJ44599I , Lot Number 21KBM267 ; DYNJ44599I , Lot Number 21LBQ208 ; DYNJ44599I , Lot Number 22NBE952 ; DYNJ44599I , Lot Number 22EBA808 ; DYNJ44599I , Lot Number 22EBV387 ; DYNJ44599I , Lot Number 22GBL830 ; DYNJ44599I , Lot Number 22HBM625 ; DYNJ44599I , Lot Number 22IBN180 ; DYNJ44599I , Lot Number 22JBH998 ; DYNJ44599I , Lot Number 22JBX287 ; DYNJ44599I , Lot Number 23ABJ748 ; DYNJ44599I , Lot Number 23BBO863 ; DYNJ44599I , Lot Number 23CBU289 ; DYNJ44599I , Lot Number 23DBO841 ; DYNJ44599I , Lot Number 23EBP969 ; DYNJ44599I , Lot Number 23GBG623 ; DYNJ44599I , Lot Number 23HBR164 ; DYNJ44599I , Lot Number 20EBC852 ; DYNJ44599I , Lot Number 23IBU633 ; DYNJ44599I , Lot Number 20FBO439 ; DYNJ44599I , Lot Number 20GBA511 ; DYNJ44599I , Lot Number 23KBI875 ; DYNJ44599I , Lot Number 24ABA732 ; DYNJ44599I , Lot Number 20JBA956 ; DYNJ44599I , Lot Number 20JBZ002 ; DYNJ44599I , Lot Number 20KBD800 ; DYNJ44599I , Lot Number 20LBI387 ; DYNJ44599I , Lot Number 21CBN891 ; DYNJ44599I , Lot Number 21CBX162 ; DYNJ66416, Lot Number 20GKA807 ; DYNJ68767, Lot Number 21HLA622 ; DYNJ68767, Lot Number 21KLA137 ; DYNJ68767, Lot Number 21LLA666 ; DYNJ68767, Lot Number 22BLA542 ; DYNJ68767, Lot Number 22DLB131 ; DYNJ68767, Lot Number 22HLA449 ; DYNJ68767, Lot Number 22ILA208 ; DYNJ68767, Lot Number 22KLA881 ; DYNJ68767, Lot Number 23ALA469 ; DYNJ68767, Lot Number 23BLA292 ; DYNJ68767, Lot Number 23CLA817 ; DYNJ68767, Lot Number 23ELA407 ; DYNJ68767, Lot Number 23ELA587 ; DYNJ68767, Lot Number 23KLA248 ; DYNJ68767, Lot Number 23LLA473 ; P737057, Lot Number 21VBC482
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-3015-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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