FDA Medical Device Recalls (openFDA)
Carmel Pharma, Inc.: PhaSeal, Protector 50, Item No. 50, US Order No. 10310
- Recall number
- Z-1181-2007
- Recalling firm
- Carmel Pharma, Inc.
- Product
- PhaSeal, Protector 50, Item No. 50, US Order No. 10310
- Status
- Terminated
- Initiated
- 2007-06-26
- Posted
- 2007-08-22
- Terminated
- 2013-03-05
- 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
- Lot, serial or model codes
- P50 Cat. No. 22050
- 510(k) numbers
- ["K001368"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3002897967
- Firm city
- Columbus
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28