Recall Z-2463-2020
LivaNova USA Inc. · initiated April 24, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
Codes / lots: LOT 2004900018
Reason for recall
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
FDA-determined cause: Packaging process control
Action taken
The firm sent an URGENT MEDICAL DEVICE REMOVAL letter to affected customers on 04/24/2020. The purpose of this medical device correction is to: 1. Advise the customers of the present issue and not to use the affected devices; 2. Providing information to the user on product disposal or return and replacement; 3. Inform affected customers that LivaNova will coordinate replacement for the unused products.
Details
- Recall number
- Z-2463-2020
- Initiated
- April 24, 2020
- Terminated
- February 17, 2022
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 150 units
- Distribution
- US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)
- Recalling firm
- LivaNova USA Inc., Arvada, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2443-2020 Class II | Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2444-2020 Class II | Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2445-2020 Class II | Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2446-2020 Class II | Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2447-2020 Class II | Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2448-2020 Class II | Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2449-2020 Class II | Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2450-2020 Class II | Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2451-2020 Class II | Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2452-2020 Class II | Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2453-2020 Class II | Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2454-2020 Class II | Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2455-2020 Class II | Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2456-2020 Class II | Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2457-2020 Class II | Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2458-2020 Class II | 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2459-2020 Class II | 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285XXX | 04/24/2020Terminated |
| Z-2460-2020 Class II | 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2461-2020 Class II | 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2462-2020 Class II | 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2464-2020 Class II | Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |