Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0178-06

Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm *...

C.R. Bard Inc / initiated 2005-09-28 / Terminated

C.R. Bard, Inc., Urological Division began a recall of 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... on . The reason FDA records is "Varying degrees of difficulty were encountered when opening and closing the InnoValve". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0178-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
C.R. Bard Inc
Product
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.
Product code
BSY Catheters, Suction, Tracheobronchial
Reason for recall
Varying degrees of difficulty were encountered when opening and closing the InnoValve.
FDA root cause
Other
Action
Consignees were notified via Federal Express letter on/about 09/28/2005.
Quantity in commerce
10169 units
Distribution
Nationwide
Product codes and lots
Catalog Number: 220059, Lot Numbers: NGPD0713, NGPD0714, NGPE11, Catalog Number: 220067, Lot Number: NGPD2781, Catalog Number: 220068, Lot Number: NGPD0855, Catalog Number: 220069, Lot Numbers: NGPD0939, NGPD1735, NGPD2015, NGPE0403, NGPE0404, Catalog Number: 220141, Lot Number: NGPE1200, Catalog Number: 220145, Lot Number: NGPD0934, Catalog Number: 220155, Lot Number: NGPD2697, Catalog Number: 220211, Lot Number: NGPE1170.