FDA Recall
Terminated
Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult Disposable Anesthesia Breathing Circuit ***1-Breathing Bag Non-Latex***.
Recall: Z-0463-05
·
Initiated April 1, 2004
Recall
- Recall Number
- Z-0463-05
- Event Number
- 30642
- Firm
- Smiths Medical ASD, Inc.
- FEI Number
- 1217052
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 1, 2004
- Posted
- February 1, 2005
- Terminated
- February 8, 2005
- Address
- 10 Bowman Dr, Keene, NH, 03431-5043
Description
Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult Disposable Anesthesia Breathing Circuit ***1-Breathing Bag Non-Latex***.
Reason
Mislabeled: Product labeled as non-latex actually contains a latex breathing bag.
Action
Smiths Sales Representatives and Sales Regional Manager visited the distributor and removed 33 cases.
Distribution
FL
Quantity
357 cases