Recall Z-1529-2013 ยท DQY Catheter, Percutaneous
Bard Peripheral Vascular Inc
USHER Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher Peripheral is available in a length 130 cm
| Date | Jun 10, 2013 (initiated Jan 23, 2013) |
| Status | Terminated |
| Reason | 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 | 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 prod |
| Quantity | 223 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090547 | ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U C.R. Bard, Inc., Mar 18, 2009 |