Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
Summary
The FDA issued a Class II for Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Nu 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-2989-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
Lot/Code Info: DYNJRA9026 , Lot Number 22EBN191 ; DYNJRA9026 , Lot Number 22LBC356 ; DYNJRA9026 , Lot Number 23ABN403 ; DYNJRA9026 , Lot Number 23CBP475 ; DYNJRA9026 , Lot Number 23DBG934 ; DYNJRA9026 , Lot Number 23EBH050 ; DYNJRA9026 , Lot Number 23JBS641 ; DYNJRA9026 , Lot Number 23KBJ179 ; DYNJRA9026 , Lot Number 23LBU686 ; DYNJRA9026 , Lot Number 19ADC324 ; DYNJRA9026 , Lot Number 19ADD208 ; DYNJRA9026 , Lot Number 19LDA087 ; DYNJRA9026 , Lot Number 19LDB132 ; DYNJRA9026 , Lot Number 20ADC808 ; DYNJRA9026 , Lot Number 20BDA346 ; DYNJRA9026 , Lot Number 20BDB555 ; DYNJRA9026 , Lot Number 20CDB731 ; DYNJRA9026 , Lot Number 20EDC526 ; DYNJRA9026 , Lot Number 20GDA908 ; DYNJRA9026 , Lot Number 20IDA046 ; DYNJRA9026 , Lot Number 20IDA621 ; DYNJRA9026 , Lot Number 20LDB113 ; DYNJRA9026 , Lot Number 20LDB323 ; DYNJRA9026 , Lot Number 21BDA498 ; DYNJRA9026 , Lot Number 21DDA458 ; DYNJRA9026 , Lot Number 21DDA663 ; DYNJRA9026 , Lot Number 21HDC456 ; DYNJRA9026 , Lot Number 21JDB091 ; DYNJRA9026 , Lot Number 21KDC632 ; DYNJRA9026 , Lot Number 21LDA581 ; DYNJRA9026 , Lot Number 21LDB014 ; DYNJRA9026 , Lot Number 22BDA209 ; DYNJRA9026 , Lot Number 22BDC191 ; DYNJRA9026 , Lot Number 22CDA655 ; DYNJRA9026 , Lot Number 22CDC010 ; DYNJRA9026 , Lot Number 22ILB005 ; DYNJRA9026 , Lot Number 22KLA115
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-2989-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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