*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 6

FDA device recall Z-2193-2013 · posted 2013-09-11 · Terminated

Recall details

Recalling firm

Carefusion 2200 Inc

Reason for recall

Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.

Action taken

Recall notification letters dated 8/27/13 were distributed via courier to direct accounts. Consignees were/are requested to confirm receipt of the notification, examine their inventory for the recalled products and to destroy the products. After the products are destroyed, the consignees are requested to submit a completed response form to CareFusion for replacement with functional devices. Consignees who cannot destroy the affected products are requested to contact CareFusion for additional information.

Root cause

Process change control

Status

Terminated

Product code

GCB

Quantity affected

*** 1) 174,580 units; *** 2) 23,330 units

Distribution

Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MD, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA,

Date initiated

2013-08-28

Date posted

2013-09-11

Date terminated

2015-06-16

Location

Vernon Hills, IL