ClearanceBrief
Recall Z-0998-03 ยท

Portex Ltd.

Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number: 100/179/050

DateJul 19, 2003 (initiated May 16, 2003)
StatusTerminated
ReasonTracheal tubes may be non-sterile
Root causeOther
ActionPortex 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.
Quantity110 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.