REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen

FDA device recall Z-0269-2019 · posted 2018-11-07 · Terminated

Recall details

Recalling firm

OriGen Biomedical, Inc.

Reason for recall

Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage

Action taken

On April 1, 2015 the firm sent an MEDICAL DEVICE MARKET WITHDRAWAL to customers/distributors via email to inform them the catheters may start to show signs of failure at the junction of the clear extension tube and blue hub connection that can be recognized by air entrainment or blood leakage. If the preliminary failure is identified, the catheter should be replaced immediately. Serious injuries could occur due to the failure mode. The customers are instructed to discontinue use of all products from the affected lot and to return any unused products immediately and to complete and return the acknowledgement and receipt form even if the customer does not currently have products in its inventory. The firm is conducting an investigation to determine root cause of the failure and will notify the customers when the investigation has been completed and when replacement products are available. If customers have any questions regarding the return of product or the status of the investigation, they can contact: OriGen Biomedical Attn: Bernie R Silvers 7000 Burleson Road, Building D Austin, TX 78744 Phone Number +1 512-474-7278

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

DWF

Quantity affected

134

Distribution

Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Pola

Date initiated

2015-03-30

Date posted

2018-11-07

Date terminated

2024-03-01

Location

Austin, TX

Related 510(k) clearances