Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, P
Summary
The FDA issued a Class I for Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 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-2443-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
Lot/Code Info: DYNJ59089 , Lot Number 23IBF074 ; DYNJRA1221A , Lot Number 20IDB255 ; DYNJRA1221A , Lot Number 22BDA978 ; DYNJRA1221A , Lot Number 22KDA950 ; DYNJRA1221A , Lot Number 22LDA146 ; DYNJRA1221A , Lot Number 23ADB422 ; DYNJRA1221A , Lot Number 23BDB453 ; DYNJRA1221A , Lot Number 23IDA424 ; DYNJRA1221A , Lot Number 23JDB010
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-2443-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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