Z-1527-2013Class II

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

Name: Z-1527-2013 BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue...
Creator: Bard Peripheral Vascular Inc
Published: 2013-01-23
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2013-01-23 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced... on 2013-01-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1527-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-23
Posted: 2013-06-10
Terminated: 2013-06-10
Recalling firm: Bard Peripheral Vascular Inc
Product: BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
Product code: NEU Marker, Radiographic, Implantable
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] with any questions.
Quantity in commerce: 315
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.
Product codes and lots: PC 863017D; Lot: HUWL0010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1527-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1526-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-10
Z-1527-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-10
Z-1528-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-10
Z-1529-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-10

Product code NEU

K090547Class IIUltraclip II US Wing and Coil, Models: 862017U, 864017UC.R. Bard, Inc. / cleared 2009-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)