Summary
The FDA issued a Class II for Soft Tissue Biopsy Needles by M.D.L. S.r.l.. Reason: Sterility assurance may be compromised..
Details
Source
Device Recall
External ID
Z-2492-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
Soft Tissue Biopsy Needles
Lot/Code Info: Model MGK11210, Lot Numbers: 5216C Model MGK11410, Lot Numbers: 5216C, 1217B, 3620D Model MGK11413, Lot Numbers: 5216C Model MGK11415, Lot Numbers: 3620D Model MGK11610, Lot Numbers: 5216C, 3620D Model MGK11615, Lot Numbers: 3620D Model MGK11616, Lot Numbers: 5216C, 1217B Model MGK11620, Lot Numbers: 1617A Model MGK11810, Lot Numbers: 5216C Model MGK11816, Lot Numbers: 5216C Model MGK11820, Lot Numbers: 5216C, 1217B, 4617 Model MGK11825, Lot Numbers: 5216C, 1217B, 3620D, 3620E Model PD01415, Lot Numbers: 3620D, 3620E Model PD01416, Lot Numbers: 5216C, 1417A Model PD01420, Lot Numbers: 5216C Model PD01610, Lot Numbers: 5216C, 0817A, 0818, 1618A, 1918A, 3620D, 3620E Model PD01615, Lot Numbers: 3620D, 3620E Model PD01616, Lot Numbers: 5216C, 1417A Model PD01620, Lot Numbers: 5216C Model PD01810, Lot Numbers: 5216C, 0817A, 0817A, 1617A, 0818, 1618A, 1918A Model PD01816, Lot Numbers: 5216C, 0817A, 0817A, 1617A Model PD01820, Lot Numbers: 5216C, 2217A, 2217A Model PD02007, Lot Numbers: 1617A, 2217A, 0119 Model PD02010, Lot Numbers: 5216C, 0817A, 2217A, 1918A Model PD02016, Lot Numbers: 5216C, 0817A, 2217A Model PD02020, Lot Numbers: 5216C, 0817A Model PD0PP1407, Lot Numbers: 0718 Model PD0PP1410, Lot Numbers: 5216C, 3620D, 3620E Model PD0PP1415, Lot Numbers: 3620D, 3620E Model PD0PP1416, Lot Numbers: 5216C Model PD0PP1420, Lot Numbers: 5216C Model PD0PP1610, Lot Numbers: 5216C, 4018, 1119A, 3620D, 3620E Model PD0PP1615, Lot Numbers: 3620D, 3620E, 4220C Model PD0PP1616, Lot Numbers: 5216C, 1119A Model PD0PP1620, Lot Numbers: 5216C Model PD0PP1807, Lot Numbers: 4018, 0219 Model PD0PP1810, Lot Numbers: 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1815, Lot Numbers: 1417C Model PD0PP1816, Lot Numbers: 5216C, 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1820, Lot Numbers: 5216C, 1417A, 2217A, 2618B, 0219, 1119A Model PD0PP1825, Lot Numbers: 5216C, 1417A Model PD0PP2007, Lot Numbers: 1617A, 0119, 0219 Model PD0PP2010, Lot Numbers: 0417, 1417A, 2217A, 0918, 0219 Model PD0PP2016, Lot Numbers: 1417A, 2217A, 0818A, 0818B, 1218A, 0219, 1119A Model PD0PP2020, Lot Numbers: 1417A, 2217A, 0219, 1119A Model TY1410, Lot Numbers: 5216C, 1417A, 1817, 1618A, 3620D Model TY1412, Lot Numbers: 1617A Model TY1416, Lot Numbers: 5216C, 1417A Model TY1420, Lot Numbers: 1417A Model TY1610, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1612, Lot Numbers: 1618A Model TY1616, Lot Numbers: 5216C, 0817 Model TY1620, Lot Numbers: 5216C Model TY1810, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1812, Lot Numbers: 2217, 1618A Model TY1816, Lot Numbers: 5216C Model TY1820, Lot Numbers: 5216C, 1417A, 1417C, 0818, 1618A, 1918A Model TY1825, Lot Numbers: 5216C, 2217A, 1618A, 3620D Model TY1830, Lot Numbers: 1618A Model TY2010, Lot Numbers: 5216C Model TY2016, Lot Numbers: 5216C Model TY2020, Lot Numbers: 5216C, 1417A Model TYC1410, Lot Numbers: 5216C, 1417A Model TYC1412, Lot Numbers: 1617A Model TYC1416, Lot Numbers: 5216C Model TYC1810, Lot Numbers: 5216C, 2217A Model TYC1812, Lot Numbers: 2217 Model TYC1816, Lot Numbers: 5216C, 2217A Model TYC1820, Lot Numbers: 1417A, 2117A Model TYC2010, Lot Numbers: 5216C, 2217A Model TYC2016, Lot Numbers: 5216C, 2217A Model TYC2020, Lot Numbers: 1417A, 2117A, 2217A
Quantity Affected: 20,129 units
Reason for Recall
Sterility assurance may be compromised.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-05
Company
Delebio
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 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
M.D.L. S.r.l. has 5 FDA actions in our database, including 5 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 (M.D.L. S.r.l.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does M.D.L. S.r.l. have FDA actions?
M.D.L. S.r.l. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2492-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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