Summary
The FDA issued a Class II for Aspirated Cyto-Histological Biopsy needle by M.D.L. S.r.l.. Reason: Sterility assurance may be compromised..
Details
Source
Device Recall
External ID
Z-2490-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
Aspirated Cyto-Histological Biopsy needle
Lot/Code Info: Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A
Quantity Affected: 2750 devices
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-2490-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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