SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
WELL LEAD MEDICAL CO. LTD · The 6Fr suction catheter could not pass through the samples smoothly.
Open FDA's page for this record- Cfres ID
- 222198
- Product res number
- Z-3172-2026
- Event date initiated
- 2026-07-31
- Event date posted
- 2026-09-15
- Recall status
- Open, Classified
- Res event number
- 99685
- Product code
- BTR
- Product description
- SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
- Firm FEI number
- 3010400865
- Recalling firm
- WELL LEAD MEDICAL CO. LTD
- Address 1
- NO. 47 Guomao Avenue South , Panyu NO. 47 Guomao Avenue South Panyu
- City
- Guangzhou
- Country
- China
- Additional info contact
- Bin Chen +86 20 84758878
- Reason for recall
- The 6Fr suction catheter could not pass through the samples smoothly.
- Root cause description
- Process control
- Product quantity
- 27200
- Distribution pattern
- US Nationwide distribution in the state of MI.
- Code info
Model Number: 1-7333-25; UDI-DI:10889483048108; Lot No.: 2108011462, 2108011506, 2109011963, 2111012039, 2112012040, 2204010568, 2204010569, 2204010734, 2205010833, 2207011263, 2208011729, 2208011789, 2304010830, 2306011372, 2306011425, 2308011907, 2308012011, 2308012012, 2309012128, 2310012358, 2310012599, 2311013016, 2311012924, 2312013223, 2401010069, 2401010197, 2402010378, 2403010466, 2403010889, 2404010999, 2406011822, 2407012282, 2408012389, 2409012800, 2409012882, 2508013006, 2510013653, 2511014081, 2512014080, 2602010272, 2603010274, 2603010900, 2604011014, 2604011416, 2605011923, 2605011924;
- Action
On July 31, 2026 URGENT: MEDICAL DEVICE RECALL letters were emailed to customers. Actions to be taken: 1. We request that you check your inventory for product within the scope of this recall. Quarantine all impacted product immediately. Cease use and distribution immediately. 2. If the affected product is currently in use on a patient, do not perform a prophylactic endotracheal tube exchange solely due to this notification. Continue to manage the patient according to institutional protocols and clinical judgment. 3. If you do have stock in scope of this recall, mark the applicable checkbox on the Affected Product Information Table and contact Well Lead by E-mail . 4. If you do not have stock in scope of this recall, mark the applicable checkbox on the Affected Product Information Table and return the form to the E-mail address . 5. For affected products, please contact your distributor to arrange product replacement.
- K numbers
- K042683
- Harmonized identifiers (openFDA)
- Device name
- Tube, Tracheal (W/Wo Connector)
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5730
- Device class
- 2
- K number
- K791045, K071365, K912290, K833807, K190878, K843936, K812879, K862238, K241451, K113333, K082038, K871263, K091591, K864161, K171411, K781713, K233341, K915277, K833831, K844296, K930741, K984528, K921077, K111401, K223130, K852493, K141939, K780900, K141747, K190274, K243785, K926498, K161813, K822082, K190630, K790312, K812943, K893609, K894669, K880960 +202 more
- Registration number
- 3015443199, 3007740622, 3005609751, 9617604, 3005580113, 3011050534, 3006157842, 3012050423, 3021632375, 1314417, 2431166, 3010220595, 3016844398, 3004111573, 3004748541, 1820334, 3014544429, 3004527595, 3004569180, 3009526575, 3007502289, 3030733800, 3004365956, 1718873, 1643817, 1048735, 9681384, 3011237770, 3003935342, 2031966, 3043226252, 3016438694, 3007289408, 3007728072, 1219795, 3007713076, 3004992992, 3043543260, 3010202439, 1018233 +94 more
- FEI number
- 3002980729, 3015443199, 3007740622, 3005609751, 3005580113, 3011050534, 3006157842, 3012050423, 3021632375, 3002807626, 1314417, 3010220595, 3016844398, 3004111573, 3004748541, 1820334, 3014544429, 3004527595, 3004569180, 1000125147, 3009526575, 3007502289, 3009271244, 3004365956, 3030733800, 1718873, 1643817, 1048735, 1000518731, 3011237770, 3003935342, 3043226252, 3016438694, 1000511237, 3007289408, 3007475226, 3007728072, 1219795, 3007713076, 3004992992 +94 more