Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700
FDA device recall Z-0158-2013 · posted 2012-10-25 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury.
- Action taken
- Sorin Group USA, Inc. sent a Product Recall letter to all affected customers by certified mail on September 14, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to discontinue use of the affected product, return all unused product to the firm and to complete and return a Response Form via fax or email. For further questions, contact the firm at 1-800-650-2623.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTL
- Quantity affected
- 1,380 units
- Distribution
- US Nationwide Distribution in the states of: AL, AR, CA, CO, CT, FL, IL, MI, MN, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.
- Date initiated
- 2012-09-14
- Date posted
- 2012-10-25
- Date terminated
- 2013-04-23
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TUBING CONNECTORS EC-2XXX SERIES (K833322) | Gish Biomedical, Inc. | 1983-12-16 |