Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, P
Summary
The FDA issued a Class I for Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA096 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-2442-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097; 7) PAIN TRAY, Pack Number DYNJRA2230; 8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A; 9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856; 10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A; 11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047; 12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048
Lot/Code Info: DYNJRA0960C , Lot Number 23CBH823 ; DYNJRA0960C , Lot Number 23EBC905 ; DYNJRA0960C , Lot Number 23EBV028 ; DYNJRA0960C , Lot Number 23HBO071 ; DYNJRA0960C , Lot Number 24BBI322 ; DYNJRA1268C , Lot Number 22GLB081 ; DYNJRA1268C , Lot Number 22HLA566 ; DYNJRA1268C , Lot Number 22ILA092 ; DYNJRA1268C , Lot Number 22LLA800 ; DYNJRA1268C , Lot Number 23DLA368 ; DYNJRA1268C , Lot Number 23FLA942 ; DYNJRA1268C , Lot Number 23GLA321 ; DYNJRA1268C , Lot Number 23HLA910 ; DYNJRA1268C , Lot Number 23ILA593 ; DYNJRA1638C , Lot Number 23EBA854 ; DYNJRA1638C , Lot Number 23GBE493 ; DYNJRA1638C , Lot Number 23KBJ159 ; DYNJRA1928 , Lot Number 22EBD354 ; DYNJRA1928 , Lot Number 22JBO947 ; DYNJRA1928 , Lot Number 23CBO440 ; DYNJRA1928 , Lot Number 23HBK783 ; DYNJRA1928 , Lot Number 23JBI435 ; DYNJRA1928 , Lot Number 23LBM602 ; DYNJRA1928 , Lot Number 24ABQ693 ; DYNJRA2040 , Lot Number 23CBH893 ; DYNJRA2040 , Lot Number 23HBX547 ; DYNJRA2040 , Lot Number 23JBN538 ; DYNJRA2040 , Lot Number 24ABQ696 ; DYNJRA2040 , Lot Number 24CBG746 ; DYNJRA2097 , Lot Number 23BBO995 ; DYNJRA2230 , Lot Number 23JBU321 ; DYNJRA2230 , Lot Number 23LBC389 ; PAIN1766A , Lot Number 23FLB123 ; PAIN1766A , Lot Number 23GLA313 ; PAIN1766A , Lot Number 24ALA302 ; PAIN1766A , Lot Number 24BLA659 ; PAIN1766A , Lot Number 24BLA888 ; PAIN1766A , Lot Number 24BLA889 ; PAIN1766A , Lot Number 24BLA998 ; PAIN1766A , Lot Number 24CLA003 ; PAIN1766A , Lot Number 24CLA078 ; PAIN1856 , Lot Number 22JLB162 ; PAIN1856 , Lot Number 22LLA409 ; PAIN1856A , Lot Number 23HLB303 ; PAIN1856A , Lot Number 24BLB005 ; PAIN1856A , Lot Number 24BLA682 ; PAIN2047 , Lot Number 24BBH932 ; PAIN2048 , Lot Number 24BBF612
Quantity Affected: 1,679,067 units in total
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: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 158 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-2442-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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