ClearanceBrief
Recall Z-0245-06 ยท CAZ Anesthesia Conduction Kit

Smiths Medical ASD, Inc.

4950-16 Portex Epidural Mini-pack

DateNov 30, 2005 (initiated Nov 17, 2005)
StatusTerminated
ReasonTray may contain holes compromising the sterility of the device
Root causeOther
ActionSmiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

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