Bard Biopsy EnCor Probe Recall for Sterility and Function Defects
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with functional failures (leaks, suction issues) that could lead to procedural failure or potential harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 12,875 units of Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G (REF number ECP017G). The affected lots are VTCT0268, VTCT0269, VTCT0270, VTCT0271, VTCU0340, and VTCU0341. These products were distributed to various U.S. states and foreign countries, including Canada, Australia, and several European and Asian nations.
The recall was initiated because these specific lots were inadvertently not included in the scope of a previous recall. The original recall was conducted due to an increase in probe failures, specifically leaks, suction issues, and failure to obtain samples. The agency classification for this recall is Class II.
Healthcare providers and facilities should stop using the affected lots immediately. Consumers and patients should contact their healthcare provider or the recalling firm for further instructions regarding the replacement or return of these single-use, sterile devices.
The recalled product
- Product
- Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probe
- Affected units
- 12,875
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot numbers VTCT0268
- VTCT0269
- VTCT0270
- VTCT0271
- VTCU0340
- and VTCU0341. UDI numbers: (01)00801741086281(17)200601(10)VTCT0268
- (01)00801741086281(17)200601(10)VTCT0269
- (01)00801741086281(17)200601(10)VTCT0270
- (01)00801741086281(17)200601(10)VTCT0271
- (01)00801741086281(17)200601(10)VTCU0340
- and (01)00801741086281(17)200601(10)VTCU0341.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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