Contour Fabricators, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Contour Fabricators, Inc. makes
Contour Fabricators, Inc. manufactures protective and organizational medical device accessories, including sterile and disposable covers for ultrasound probes, equipment coils, and magnets, as well as restraint belts, cable holders, suction tube holders, and instrument holders. Their products are designed for single-use or reusable applications in clinical settings to maintain sterility and secure medical equipment.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with several products listed via the FDA’s 510(k) pathway. These items are intended for use in the United States and comply with applicable regulatory requirements for medical device authorization.
Catalogue
Cfi Ultrasound Probe Drape Ref K090773
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Cable Holder, Suction Tube Holder Ref K971040
Regimes: 510(k) Registry: 510(k)Ge Sterile Disposable Equipment Coil Cover Ref K964141
Regimes: 510(k) Registry: 510(k)General Equipment Cover Ref K782155
Regimes: 510(k) Registry: 510(k)Instrument Holder Ref K970900
Regimes: 510(k) Registry: 510(k)Bandbag, Wrap, Sterile Ref K820692
Regimes: 510(k) Registry: 510(k)Sterile Disposable Equipment Magnet Cover Ref K970185
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Contour Fabricators, Inc., initiated on 2016-09-09. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 9 Sep 2016 Z-0080-2017 Class II Terminated Two customer complaints
suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise)
without allowing the cable to unwind to its normal condition may cause the cable to break
suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the
Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body
shield will fall immediately. A fall of this nature places the user, associated staff and the patient
at risk for a potential injury.
Full distribution text
- 9 Sep 2016 Z-0080-2017 Class II Terminated Two customer complaints
suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise)
without allowing the cable to unwind to its normal condition may cause the cable to break
suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the
Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body
shield will fall immediately. A fall of this nature places the user, associated staff and the patient
at risk for a potential injury.
Frequently asked questions
How many devices does Contour Fabricators, Inc. have in the registry?
The registry currently lists 8 devices for Contour Fabricators, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Contour Fabricators, Inc.'s devices?
Among its 8 most recently registered devices, Contour Fabricators, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Contour Fabricators, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Contour Fabricators, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Contour Fabricators, Inc.?
FDA recall records list 1 recall initiated by Contour Fabricators, Inc., the most recent initiated on 9 Sep 2016. 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 Contour Fabricators, Inc. in the registry?
The most recently registered devices listed for Contour Fabricators, Inc. include CFI ULTRASOUND PROBE DRAPE, CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046), CABLE HOLDER, SUCTION TUBE HOLDER and GE STERILE DISPOSABLE EQUIPMENT COIL COVER.