Recall Z-1642-2023— Maquet Medical Systems USA

Name: FDA recall Z-1642-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-18

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2023-05-18. It names one FDA 510(k) clearance: K102919. Product: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445. Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2023-05-18
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102919 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHEMaquet Cardiopulmonary, AG·cleared 2011-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

Reason for recall

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Data sourced from openFDA. This site is unofficial and independent of the FDA.