ClearanceBrief
Recall Z-0211-2007 ยท CAZ Anesthesia Conduction Kit

Smiths Medical ASD, Inc.

Portex Continuous Epidural tray Ref 4948-17

DateNov 22, 2006 (initiated Oct 27, 2006)
StatusTerminated
ReasonMisbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch
Root causeOther
ActionSmith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.
Quantity540 units
DistributionNationwide and Panama
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K965017REGIONAL ANESTHESIA TRAYS
Smiths Industries Medical Systems, Inc., Mar 14, 1997