H4002S Neonatal/Paed — Class I medical device recall Z-2539-2014
Terminated recall by Smiths Medical ASD, Inc., reported 2014-09-03, distributed in AK, AR, AZ, CA, CO, CT, DC, FL…. The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty wh
| Recall number | Z-2539-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Keene, NH, United States |
| Recall initiated | 2014-07-07 |
| Classified | 2014-08-28 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2021-05-26 |
| Distributed | 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 |
| Lot numbers | 11653, 11656, 11693, 11696, 11858, 11862, 11871, 12046, 2042408, 2063970, 2063971, 2068121, 2090215, 2099501, 2109011, 2119945, 2128629, 2137959, 2142175, 2146292, 2164289, 2179222, 2188449, 2271339, 2278062, 2286586, 2298738, 2298739, 2309464, 2309465, 2317088, 2322814, 2326894, 2329576, 2343298, 2361588, 2365439, 2376489, 2376618, 2380341 and 19 more |
Product
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2539-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.