—#172821

Product

Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K080592
Affected lot / code info: Batch Numbers: 3000077890 3000079608

Why it was recalled

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Root cause (FDA determination)

Device Design

Action the firm took

Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-04-18
Posted by FDA: 2019-05-31
Terminated: 2025-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172821. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.