Recall Z-2541-2014— Smiths Medical ASD, Inc.
Class I · Terminated
Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2014-07-07, terminated 2021-05-26. FDA's recall record names no specific 510(k) clearance for this event. Product: H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit. Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-07-07
- Terminated
- 2021-05-26
- Firm location
- Keene, NH, United States
Product description
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
Reason for recall
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
Data sourced from openFDA. This site is unofficial and independent of the FDA.