H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
Reported: September 3, 2014 Initiated: July 7, 2014 #Z-2541-2014
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.
Details
- Recalling Firm
- Smiths Medical ASD, Inc.
- Units Affected
- 135,518 (110,246 nationwide)
- Distribution
- Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.
- Location
- Keene, NH
Frequently Asked Questions
What product was recalled? ▼
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit. Recalled by Smiths Medical ASD, Inc.. Units affected: 135,518 (110,246 nationwide).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2014. Severity: Critical. Recall number: Z-2541-2014.
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