Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack
Summary
The FDA issued a Class I for Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number 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-2444-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ53018; 6) CATH PACK , Pack Number DYNJ57729C ; 7) PEDS CATH PACK, Pack Number DYNJ66856; 8) PEDS CATH PACK, Pack Number DYNJ66856A ; 9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ; 10) CATH LAB PACK , Pack Number DYNJ84617; 11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A
Lot/Code Info: CMPJ08068F , Lot Number 24ABN950 ; CMPJ11455B , Lot Number 23IBD357 ; DYNJ26938J , Lot Number 22FBD709 ; DYNJ26938J , Lot Number 22GBH459 ; DYNJ26938J , Lot Number 22HBR225 ; DYNJ26938J , Lot Number 22IBJ562 ; DYNJ26938J , Lot Number 22JBP469 ; DYNJ26938J , Lot Number 23ABM365 ; DYNJ26938J , Lot Number 23CBM109 ; DYNJ26938J , Lot Number 23DBN340 ; DYNJ26938J , Lot Number 23GBH016 ; DYNJ26938J , Lot Number 23IBS867 ; DYNJ53018, Lot Number 21IBX266 ; DYNJ53018, Lot Number 22GBN555 ; DYNJ53018, Lot Number 23ABN207 ; DYNJ57729C , Lot Number 23HBK882 ; DYNJ57729C , Lot Number 24ABO025 ; DYNJ66856, Lot Number 21KBH003 ; DYNJ66856A , Lot Number 22DBD158 ; DYNJ66856A , Lot Number 22FBY433 ; DYNJ66856A , Lot Number 22GBK576 ; DYNJ66856A , Lot Number 22HBQ139 ; DYNJ66856A , Lot Number 22IBO303 ; DYNJ66856A , Lot Number 22JBO861 ; DYNJ66856A , Lot Number 22JBQ914 ; DYNJ66856A , Lot Number 23ABT952 ; DYNJ66856A , Lot Number 23CBF157 ; DYNJ66856A , Lot Number 23EBE461 ; DYNJ66856A , Lot Number 23EBI477 ; DYNJ66856A , Lot Number 23HBD973 ; DYNJ81061A , Lot Number 23HBN396 ; DYNJ84617, Lot Number 23FBR368 ; DYNJ49920L , Lot Number 23KMB066 ; UVT1190A , Lot Number 23BLA187 ; UVT1190A , Lot Number 23DLA246 ; UVT1190A , Lot Number 23KLA117 ; UVT1190A , Lot Number 23LLA329
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-2444-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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