Carmel Pharma AB.
Gothenburg, SE
Carmel Pharma Ab. appears in FDA device records in Gothenburg, SE. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Carmel Pharma AB. between 1998 and 2011. The busiest year on record is 2009, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2006 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110023 | INFUSION ADAPTER C100 | LHI | Substantially Equivalent | |
| K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, | LHI | Substantially Equivalent | |
| K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | LHI | Substantially Equivalent | |
| K060866 | PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS | LHI | Substantially Equivalent | |
| K023747 | PHASEAL | LHI | Substantially Equivalent | |
| K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER | LHI | Substantially Equivalent | |
| K980381 | PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO | LHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1181-2007 | PhaSeal, Protector 50, Item No. 50, US Order No. 10310 | 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. | Terminated | ||
| Z-1180-2007 | PhaSeal, Protector 21, Item No. 21, US Order No. 22020 | 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. | Terminated | ||
| Z-1179-2007 | PhaSeal Injector Luer Lock, Item No. 31, US Order No. 10310 | 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. | Terminated | ||
| Z-1178-2007 | PhaSeal, Protector 14, Item No. P14, US Order No. 21320 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain