Carmel Pharma AB.
SwedenFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Carmel Pharma AB. makes
Carmel Pharma Ab. manufactures medical devices for handling parenteral drugs, including infusion adapters, injectors, connectors, and closed system devices such as Phaseal and Protector series products.
The company's products are Class II medical devices listed in the FDA 510(k) registry, and the company is based in the US.
Catalogue
Infusion Adapter C100 Ref K110023
Regimes: 510(k) Registry: 510(k)Phaseal Ref K023747
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Phaseal Protector P14, P21, P28 And P50 Ref K090634
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Carmel Pharma Ab., initiated on 2007-06-26. By recorded status: 4 terminated. The reasons filed fall into these groups: packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 26 Jun 2007 Z-1178-2007 Unclassified (pre-2012) Terminated Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
- 26 Jun 2007 Z-1179-2007 Unclassified (pre-2012) Terminated Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
- 26 Jun 2007 Z-1180-2007 Unclassified (pre-2012) Terminated Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
- 26 Jun 2007 Z-1181-2007 Unclassified (pre-2012) Terminated Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
Frequently asked questions
How many devices does Carmel Pharma Ab. have in the registry?
The registry currently lists 7 devices for Carmel Pharma Ab.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carmel Pharma Ab.'s devices?
Among its 7 most recently registered devices, Carmel Pharma Ab. has devices listed in FDA 510(k) (7 devices).
What risk classes do Carmel Pharma Ab.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Carmel Pharma Ab.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Carmel Pharma Ab.?
FDA recall records list 4 recalls initiated by Carmel Pharma Ab., the most recent initiated on 26 Jun 2007. 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 Carmel Pharma Ab. in the registry?
The most recently registered devices listed for Carmel Pharma Ab. include INFUSION ADAPTER C100, PHASEAL, INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, and PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO.