Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906… recallZ-2179-2018 · Datascope Corporation · initiated Jul 27, 2017

Why it was recalled

There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 7/27/17, an Urgent Safety Alert was issued to customers of the Cardiovascular Procedure Kit with LN130B Over-pressure Safety Valves. The safety alert instructed customers to perform the following: Please examine your inventory immediately to determine if you have unused kits of the batch numbers listed. If so, please follow the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. It is possible that custom tubing kits with the affected valves may have already been used without issue. Customers were instructed to test the valve prior to use. The notice was sent to customers again on 10/3/17 and 12/12/17. On 1/11/18, Urgent Medical Device Recall letters were sent to customers. The letters included the following instructions: Terumo CVS now recommends removal of any remaining product from your inventory. A review of our records indicates that you have received the following Maquet/Getinge Custom Tubing Kit batch numbers affected by the Terumo Cardiovascular Systems Medical Device Recall (refer to information provided in the table below). Please examine your inventory immediately to determine if you have unused custom tubing kits of the batch numbers listed. If so, please remove the affected products, quarantine them and follow the instructions for returning the product to Maquet/Getinge for full credit. It is possible that custom tubing kits with the affected valves may have already been used without issue. The Terumo Cardiovascular Systems Medical Device Recall affects the Custom Tubing Kit with LN130B Over-pressure Safety Valve distributed by Maquet/Getinge having lot/batch numbers listed above; no other product lot/batch numbers that were delivered to you are affected. Instructions for returning affected product: 1. Review this notice and Terumos Medical Device Recall Notice (attached). 2. Ensure that all users (i.e. perfusionist, operating room staff and biomedical staff) receive notice

Recall details

Recall number

Z-2179-2018

Status

Terminated

Initiated by the company

Jul 27, 2017

Recalling firm

Datascope Corporation

Quantity

27

Product code

DWE

FDA submissions

K080592

Distribution

The products were distributed to the following US states: IA and FL.

Product description

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Pediatric CPB Pack BEQ-T 4906

  Datascope Corp. · Tubing, Pump, Cardiopulmonary Bypass
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 80081).

• Z-2180-2018 · Terminated
  Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, n…