FDAClass ISeptember 3, 2014

H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy recall

H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

Why was H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 2474641, 2470638, 2453454, 2448650, 2438611, 2433436, 2428205, 2412133, 2400804, 2347041, 2343292, 2326893, 2298737, 2271338, 2260550, 2211923, 2188448, 2175049, 2135974, 2099500, 2068120, 2042404, 11872, 11861

Product
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Recalling firm
Smiths Medical ASD, Inc.
Quantity
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.
Recall date
September 3, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls