H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy recall
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Why was H4001S Neonatal/Paed.Intubation Kit 2.5mm 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: 2470637, 2470636, 2457747, 2448649, 2443371, 2438610, 2438609, 2428204, 2428203, 2423483, 2412132, 2405733, 2405732, 2394049, 2394048, 2394047, 2389237, 2389236, 2385647, 2380340, 2376638, 2376473, 2371941, 2365534, 2361589, 2357817, 2357816, 2353342, 2347040, 2343290, 2339700, 2335460, 2326892, 2322812, 2309462, 2298736, 2298735, 2286584, 2278061, 2263550, 2260549, 2250041, 2233738, 2228354, 2219206, 2211922, 2208179, 2191911, 2188447, 2179221, 2175047, 2154527, 2152029, 2142174, 2128628, 2119944, 2109010, 2099495, 2090213, 2068117, 2063968, 2063967, 2042403, 12049, 12047, 12044, 11669, 11403
- Product
- H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder 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)