Bard Peripheral Vascular Inc: Medical Device Recall in 2013 - (Recall #: Z-1528-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath¿ is a single lumen catheter that has a 123cm working length and a straight tip shape

Product Classification:

Class II

Date Initiated: January 23, 2013

Date Posted: June 19, 2013

Recall Number: Z-1528-2013

Event ID: 64276

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).

Status: Terminated

Product Quantity: 17

Code Information:

PC MS17123; Lot# FCWC10010

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated