Recall Z-0182-2019
OriGen Biomedical, Inc. · initiated August 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
Codes / lots: UDI: 00816203022103, Lot: N18431, N18431-1
Reason for recall
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
FDA-determined cause: Component design/selection
Action taken
On 08/21/18, the firm, OriGen, emailed a recall notice dated 8/17/2018 to customers informing them of a nationwide recall of RDLC ECMO catheters. Customers were advised to return affected product to the firm. Customers with additional questions were advised to call 1-800-233-9014 or 1-512-474-7278. The firm also sent customers Technical Bulletin (TB) 1411 - Revision Feb 2018, Subject: Radiopacity of the Reinforced Dual Lumen Catheter (RDLC), Date: July 2015, and an Acknowledgment Receipt form to complete and return. On 09/12/18, the firm, Origen, sent another recall notice, dated 9/12/2018 which included additional affected lot numbers. TB1411 was sent to customers three additional times (Version/Customer Notification Date): R00/11/10/14, R01/07/22/15, and Revision Feb 2018/02/12/18. Consumers with questions may contact the company via telephone at 1-800 233 9014 between the hours of 08:00 and 16:30 (CDT). Customers outside the USA may contact OriGen at +1.512.474.7278. Customers may also contact the company via e-mail at ecmo@origen.com.
Details
- Recall number
- Z-0182-2019
- Initiated
- August 21, 2018
- Terminated
- July 15, 2021
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 169
- Distribution
- Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN…
- Recalling firm
- OriGen Biomedical, Inc., Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0179-2019 Class II | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0180-2019 Class II | Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0181-2019 Class II | Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0183-2019 Class II | ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0184-2019 Class II | Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |