Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0997-03

Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5 mm x 25cm Reference Number: 100/141/050

Abbott Medical / initiated 2003-05-16 / Terminated / root cause: sterility

Portex Ltd. began a recall of Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5 mm x 25cm Reference Number: 100/141/050 on . The reason FDA records is "Tracheal tubes may be non-sterile". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-0997-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
Product
Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5 mm x 25cm Reference Number: 100/141/050
Reason for recall
Tracheal tubes may be non-sterile
Root cause tag
sterility
FDA root cause
Other
Action
Portex Inc. Keene,NH initiated the recall by telephone to direct accounts on 5/16/03. A follow-up Recall Notification letter was issued by Federal Express on May 17, 2003. Dealers were asked to provide a consignee list or contact their accounts directly. Unused product is requested to be returned from the distributors and medical facilities.
Quantity in commerce
30 units
Distribution
Nationwide
Product codes and lots
Lot Numbers: 161705