Recall Z-1447-2015 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuat
| Date | Apr 14, 2015 (initiated Mar 17, 2015) |
| Status | Terminated |
| Reason | Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Bard Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/17/15 to customers. The letter informs customers of the problems identified and the actions to be taken. The customers were instructed to do the following: Do not use or further distribute any affected product; check all inventory locations within your institution; if you have further distributed any of the product, advise them of the recall and have them return the affected product to BPV; remove any idenfied product from your shelves; and complete and return the attached Recall and Effecti |
| Quantity | 29,342 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT Bard Peripheral Vascular, Inc., Feb 21, 2014 |