Tri-State Hospital Supply Corp.
United StatesFDA applicant, unverified
- Devices
- 16
- FDA recalls
- 27
At a glance
Market reach
- United States
- FDA recalls
What Tri-State Hospital Supply Corp. makes
Tri-State Hospital Supply Corp. manufactures single-use medical devices for surgical, wound care, and patient feeding applications, including vascular access products like I.V. extension sets and specimen traps, obstetric tools such as vaginal specula and circumcision clamps, infant feeding kits and tubes, and sterile disposable instruments for dental and hygiene procedures. Their portfolio also includes transparent film dressings, copolyester film dressings, and umbilical catheters designed for neonatal care.
The company’s devices are regulated under the FDA’s 510(k) pathway and fall into Class I, Class II, and Unclassified (U) risk categories. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Search and filter all 16 devicesFDA recalls
2009
- 14 Jan 2009 Z-1157-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1158-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1159-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1160-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1161-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1162-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1163-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1164-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1165-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1166-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
Show the 25 most recent of 27 recalls
2009
- 14 Jan 2009 Z-1167-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1168-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1169-2009 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1319-2009 Unclassified (pre-2012) Terminated Compromised sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1320-2009 Unclassified (pre-2012) Terminated Compromised sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1321-2009 Unclassified (pre-2012) Terminated Compromised sterility, as the package seals may be inadequate.
- 14 Jan 2009 Z-1322-2009 Unclassified (pre-2012) Terminated Compromised sterility, as the package seals may be inadequate.
2008
- 8 Apr 2008 Z-1571-2009 Unclassified (pre-2012) Terminated The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
- 8 Apr 2008 Z-1572-2009 Unclassified (pre-2012) Terminated The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
- 8 Apr 2008 Z-1573-2009 Unclassified (pre-2012) Terminated The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
- 8 Apr 2008 Z-1574-2009 Unclassified (pre-2012) Terminated The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
- 8 Apr 2008 Z-1575-2009 Unclassified (pre-2012) Terminated The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
2007
- 26 Oct 2007 Z-0729-2008 Unclassified (pre-2012) Terminated Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label.
- 26 Oct 2007 Z-0730-2008 Unclassified (pre-2012) Terminated Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label.
2005
- 12 Apr 2005 Z-0836-05 Unclassified (pre-2012) Terminated Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.
Frequently asked questions
How many devices does Tri-State Hospital Supply Corp. have in the registry?
The registry currently lists 16 devices for Tri-State Hospital Supply Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tri-State Hospital Supply Corp.'s devices?
Among its 16 most recently registered devices, Tri-State Hospital Supply Corp. has devices listed in FDA 510(k) (16 devices).
What risk classes do Tri-State Hospital Supply Corp.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Tri-State Hospital Supply Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Tri-State Hospital Supply Corp.?
FDA recall records list 27 recalls initiated by Tri-State Hospital Supply Corp., the most recent initiated on 14 Jan 2009. 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 Tri-State Hospital Supply Corp. in the registry?
The most recently registered devices listed for Tri-State Hospital Supply Corp. include CENTURION CIRCLAMP, COPOLYESTER FILM DRESSING, INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT and CENTURION DISPOSABLE INSTRUMENTS.