PhaSeal, Protector 21, Item No. 21, US Order No. 22020
FDA device recall Z-1180-2007 · posted 2007-08-22 · Terminated
Recall details
- Recalling firm
- Carmel Pharma, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 6.1 million for Z-1178-1181-2007 recalls
- Distribution
- Product was distributed throughout the US and Canada
- Date initiated
- 2007-06-26
- Date posted
- 2007-08-22
- Date terminated
- 2013-03-05
- Location
- Columbus, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER (K001368) | Carmel Pharma Ab. | 2000-05-12 |