Device product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Z-1568-2026
Product summary
- Firm
- Erbe USA Inc
- Event
- Event 98429
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3603 units
- Official record key
device-enforcement:Z-1568-2026
Official wording
Reason: Probes may rupture/burst during activation
Code information: UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863
Distribution pattern: US Nationwide distribution, including Puerto Rico.
Derived failure modes
-
Unknown
Probes may rupture/burst during activation