—#134572

Product

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 actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K133948
Affected lot / code info: Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Ste 109, Tempe, Arizona 85281-2438

Distribution

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

Timeline

Recall initiated: 2015-03-17
Posted by FDA: 2015-04-14
Terminated: 2015-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134572. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.