Recall Z-1178-2007 ยท FPA Set, Administration, Intravascular
Carmel Pharma, Inc.
PhaSeal, Protector 14, Item No. P14, US Order No. 21320
| Date | Aug 22, 2007 (initiated Jun 26, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers. |
| Quantity | 6.1 million for Z-1178-1181-2007 recalls |
| Distribution | Product was distributed throughout the US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER Carmel Pharma Ab., May 12, 2000 |