HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Summary
The FDA issued a Class II for HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) by AMD Medicom Inc.. Reason: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the product.
Details
Source
Device Recall
External ID
Z-1146-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Lot/Code Info: Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;
Quantity Affected: 720 cases (10 boxes/case and 50 masks/box)
Reason for Recall
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Distribution
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
Montreal, N/A
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 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AMD Medicom Inc. 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 (AMD Medicom Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AMD Medicom Inc. have FDA actions?
AMD Medicom Inc. 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-1146-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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