Bard Max-Core Biopsy Instruments Recalled for Malfunction
Bard Peripheral Vascular Inc is recalling 110,550 Max-Core Disposable Core Biopsy Instruments due to increased complaints of failure to prime, fire, or 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. The hazard involves a medical device malfunction (failure to fire/obtain sample) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 110,550 units of the BARD MAX-CORE Disposable Core Biopsy Instrument. The affected product codes are MC1410, MC1616, MC1816, MC1820, and MC1825. These devices are intended for use in obtaining biopsies from soft tissues.
The recall was initiated after a review of May 2017 complaint data revealed a significant increase in reports of device malfunctions. Specific issues identified include failure to prime, failure to fire, failure to obtain a sample, and self-activation.
The recalled units were distributed in the US, Australia, Canada, Europe, the Middle East, Africa, Latin America, and Asia Pacific. Specific lot numbers are listed in the agency's recall record. Healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 110,550
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: REBP0019
- REBN0342
- REBN2123
- REBP1199
- REBP1419
- REBP1807
- REBQ0084
- REBQ0343
- REBQ1012
- REBP1420
- REBP1809
- REBP0869
- REBP1266
- REBP1267
- REBP1421
- REBP1422
- REBP1810
- REBQ0087
- REBQ0088
- REBQ0347
Distribution
Distribution scope not specified by the agency.
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