Summary
The FDA issued a Class II for TMJ Arthroscopy Drape, 85''x 96'' by Microtek Medical Inc.. Reason: Latex content in product was labeled incorrectly as latex free..
Details
Source
Device Recall
External ID
Z-1071-2022
Action Date
2022-05-18
Status
Terminated
Category
device
Product Description
TMJ Arthroscopy Drape, 85''x 96''
Lot/Code Info: SKU Number 3601; Lot code/Expiration Date: Lot D181232, exp. 05/01/2022; Lot D181982, exp. 07/01/2022; Lot D202232, exp.08/01/2024; Lot D210742, exp. 03/01/2025; Lot D211372, exp. 05/01/2025; Lot D212562, exp. 09/01/2025; Lot D213122, exp. 11/01/2025; and Lot D213402, exp. 12/01/2025. UDI: 50748426008556
Quantity Affected: 12 cases (120 drapes)
Reason for Recall
Latex content in product was labeled incorrectly as latex free.
Distribution
Distributed nationwide to CO, PA, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-08
Company
Saint Paul, MN
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.
Microtek Medical Inc. has 9 FDA actions in our database, including 9 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 (Microtek Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microtek Medical Inc. have FDA actions?
Microtek Medical Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1071-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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