Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biops

FDA device recall Z-1447-2015 · posted 2015-04-14 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

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.

Action taken

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 Effectiveness Check Form to BPV by fax at (800) 994-6772, if you cannot FAX the form, call the BPV telephone number provided on the form and report the required information verbally. BPV will provide replacement product for your returned product. Customers are instructed to call BPV's Recall Coordinator at 1-800-321-4254 Option #2 Ext 2988 (M-F 7am to 4pm MST) or email at HUrandy.hopkins@crbard.comUH.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KNW

Quantity affected

29,342 units

Distribution

Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.

Date initiated

2015-03-17

Date posted

2015-04-14

Date terminated

2015-08-03

Location

Tempe, AZ

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