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H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn… recallZ-2537-2014 · Smiths Medical ASD, Inc. · initiated Jul 7, 2014

Class I Terminated All recalls posted in August 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process change control

What the company is doing

Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to [email protected]. Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361. For questions regarading this recall call 866-216-8806.

Recall details

Recall number
Z-2537-2014
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jul 7, 2014
Posted by the FDA
Aug 28, 2014
Recalling firm
Smiths Medical ASD, Inc.
Quantity
135,518 (110,246 nationwide)
Product code
BTR
FDA submissions
K790312
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.

Product description

H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

28 devices cleared under K790312 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68739).

Sources and updates

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