Erbe flexible cryoprobe 20402-401 recalled as Class I over rupture
Erbe USA is recalling the Flexible Cryoprobe REF 20402-401 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Erbe USA Inc is recalling the Flexible Cryoprobe (OD 1.1 mm, L1.15 mm) with oversheath (OD 2.6 mm, L 817 mm), REF 20402-401, sterile EO, for surgical use. About 64,216 units were distributed nationwide in the United States including Puerto Rico.
The probes may rupture or burst during activation. The FDA has classified this recall as Class I, its most serious category.
Affected product carries UDI 04050147021785, across an extensive list of lot numbers beginning WO471345.
Facilities can identify affected probes by the REF, UDI and lot numbers above, and may contact Erbe USA Inc for further information.
The recalled product
- Product
- Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
- Manufacturer
- Erbe USA Inc
- Category
- Medical Device — Cryosurgery
- Hazard
- probe-rupture
- surgical-risk
- class-i-recall
Distribution
Distributed nationwide across the United States.
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