3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Summary
The FDA issued a Class I for 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 by Fresenius Medical Care Holdings, Inc.. Reason: There is a potential for blood backfill leakage and foreign material..
Details
Source
Device Recall
External ID
Z-0007-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
Product Description
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Lot/Code Info: UDI-DI: 16945060500101; All Lots
Quantity Affected: 124,773 boxes total
Reason for Recall
There is a potential for blood backfill leakage and foreign material.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-08
Company
Waltham, MA
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 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 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 (Fresenius Medical Care Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Holdings, Inc. have FDA actions?
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0007-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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