BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g

FDA device recall Z-1526-2013 · posted 2013-06-10 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).

Action taken

The firm, BARD Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter on January 23, 2013, to its customers. Bard EXPANDED its recall to include (MicroSheath and Usher support Catheters) and sent another "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 5, 2013 describing the additional products, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Do not use or further distribute any affected product; check all inventory locations within your institution; remove any identified product from your shelves and return to Bard Peripheral Vascular, Inc. 1415 W. 3rd Street, Tempe, AZ 85281; if you have further distributed any of the product, immediately contact that location and advise them of the recall and have them return to BPV; If you have used the affected product, consider notifying, educating and monitoring those affected; and complete and return the Recall and Effectiveness Check form via fax to: ATTN; Recall Coordinator in Customer Service at 1-800-994-6772, even if you no longer have possession of the product; if unable to FAX call BPV at 1-800-321-4254 Option #2 Ex 2727 and report verbally. Please call our Recall Coordinator at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at HUsilvia.carrillo@crbard.com with any questions.

Root cause

Process control

Status

Terminated

Product code

NEU

Quantity affected

815

Distribution

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.

Date initiated

2013-01-23

Date posted

2013-06-10

Date terminated

2013-06-10

Location

Tempe, AZ

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