Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about 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 involves a high-risk medical device where the defect (failure to obtain samples) poses a risk of harm or diagnostic failure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes, catalog/REF number 10G - REF ECP0110G. These single-use, prescription medical devices are indicated for acquiring tissue to diagnose breast abnormalities. The recall involves 36,640 units distributed worldwide, including the United States, Puerto Rico, and numerous foreign countries.
The recall was initiated due to an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. The affected lot numbers are VTCT0306, VTCT0307, VTCU0358, VTCU0359, VTCU0360, VTCU0361, VTCV0369, VTCW0454, VTCW0455, VTCW0456, VTCW0479, VTCX0482, VTCX0483, VTCX0484, VTCY0536, VTCY0544, VTCY0545, VTCY0546, VTCY0547, VTCZ0637, VTCZ0638, VTCZ0639, VTCZ0641, VTCZ0647, VTDN0035, and VTDN0036.
Healthcare providers and facilities should stop using the affected products and contact Bard Peripheral Vascular Inc for further instructions. Consumers should not use these products and should contact their healthcare provider if they have questions regarding the recall.
The recalled product
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probes
- Affected units
- 36,640
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 (20)
- Lot numbers VTCT0306
- VTCT0307
- VTCU0358 VTCU0359
- VTCU0360
- VTCU0361
- VTCV0369
- VTCW0454
- VTCW0455
- VTCW0456
- VTCW0479
- VTCX0482
- VTCX0483
- VTCX0484
- VTCY0536
- VTCY0544
- VTCY0545
- VTCY0546
- VTCY0547
- VTCZ0637
- VTCZ0638
Distribution
Part of a larger recall action
This product is one of 6 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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