FDA Device recall Z-1726-2019
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile by Stryker, citing the heated tube sets were consistently leaking and detaching from the cassette.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1726-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-07 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker |
| Distribution | US |
Product
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Reason
The heated tube sets were consistently leaking and detaching from the cassette.
Identifiers
| code_info | UDI - 07613327055634 Lot numbers: 18G0269, 18H0353, 18K0379 , 56004320, 56004325, 56004329, 56004356, 56004366, 56…UDI - 07613327055634 Lot numbers: 18G0269, 18H0353, 18K0379 , 56004320, 56004325, 56004329, 56004356, 56004366, 56004373, 56004384, 56004387, 56004426, 56004432, 56004441, 56004443, 56004451, 56004459, 56004461, 56004487, 56004494, 56004502, 56004508, 56004515, 56004518, 56004528, 56004551, 56004565, 56004573, 56004584, 56004600, 56004614, 56004616, 56004624, 56004628, 56004632, 56004681, 56004686, 56004696, 56004704, 56004719, 56004721, 56004735, 56004737, 56004739, 56004748, 56004750, 56004760, 56004771, 56004791, 56004795, 56004809, 56004811, 56004816, 56004818, 56004820, 56004822, 56004826, 56004830, 56004842, 56004844, 56004846, 56004852, 56004881, 56004909, 56004913, 56004919, 56004925, 56004927, 56004929, 56004938, 56004950, 56004955, 56004957, 56004959, 56004970, 56004974, 56004976, 56004995, 56005003, 56005016, 56005018, 56005020, 56005097, 56005099, 56005104, 56005108, 56005128, 56005130, 56005132, 56005139, 56005198, 56005200, 56005206, 56005212, 56005229, 56005232, 560 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1726-2019%22
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