Summary
The FDA issued a Class II for Tenaculum, Plastic by Stradis Medical, LLC dba Stradis Healthcare. Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards..
Details
Source
Device Recall
External ID
Z-0126-2022
Action Date
2021-10-27
Status
Ongoing
Category
device
Product Description
Tenaculum, Plastic
Lot/Code Info: Part Number: 356T
Quantity Affected: 2483 kits
Reason for Recall
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Distribution
Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-10
Company
Peachtree Corners, GA
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 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stradis Medical, LLC dba Stradis Healthcare has 93 FDA actions in our database, including 93 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 (Stradis Medical, LLC dba Stradis Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stradis Medical, LLC dba Stradis Healthcare have FDA actions?
Stradis Medical, LLC dba Stradis Healthcare has 93 FDA actions in our database, including 93 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0126-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29