ClearanceBrief
Recall Z-0178-06 ยท BSY Catheters, Suction, Tracheobronchial

C.R. Bard, Inc., Urological Division

Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.

DateNov 23, 2005 (initiated Sep 28, 2005)
StatusTerminated
ReasonVarying degrees of difficulty were encountered when opening and closing the InnoValve.
Root causeOther
ActionConsignees were notified via Federal Express letter on/about 09/28/2005.
Quantity10169 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.