Rx Textiles, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Rx Textiles, Inc. makes
Rx Textiles, Inc. manufactures sterile stockinette, a non-adherent, breathable fabric used primarily in medical settings for wound care, compression therapy, and patient immobilization.
The company’s products are regulated as Class II devices under FDA guidelines and are listed via the 510(k) clearance process. The portfolio is based in the United States.
Catalogue
Rx Textiles Sterile Stockinette Ref K960803
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Rx Textiles, Inc., initiated on 2003-06-11. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 11 Jun 2003 Z-1074-03 Unclassified (pre-2012) Terminated Product may not be sterile.
Frequently asked questions
How many devices does Rx Textiles, Inc. have in the registry?
The registry currently lists 1 device for Rx Textiles, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rx Textiles, Inc.'s devices?
Among its 1 most recently registered device, Rx Textiles, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Rx Textiles, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Rx Textiles, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rx Textiles, Inc.?
FDA recall records list 1 recall initiated by Rx Textiles, Inc., the most recent initiated on 11 Jun 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Rx Textiles, Inc. in the registry?
The most recently registered devices listed for Rx Textiles, Inc. include RX TEXTILES STERILE STOCKINETTE.