Recall Z-1426-2018

Carefusion 2200 Inc · initiated February 23, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

Codes / lots: Product Code: TPK1001 / LOT 0000837811, 0000842215, 0000840336, 0000851185

Reason for recall

The integrity of the sterile packaging is potentially compromised.

FDA-determined cause: Package design/selection

Action taken

On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.

Details

Recall number
Z-1426-2018
Initiated
February 23, 2017
Terminated
July 9, 2019
Product code
FSH – Tray, Surgical, Needle
Quantity
1200 units
Distribution
Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
Recalling firm
Carefusion 2200 Inc, Vernon Hills, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1421-2018 Class IIManometer, 550 ml three-Way Stopcock; STERILE;The integrity of the sterile packaging is potentially compromised. 02/23/2017Terminated
Z-1422-2018 Class IIJAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM…The integrity of the sterile packaging is potentially compromised. 02/23/2017Terminated
Z-1423-2018 Class IIILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;The integrity of the sterile packaging is potentially compromised. 02/23/2017Terminated
Z-1424-2018 Class IIJAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6…The integrity of the sterile packaging is potentially compromised. 02/23/2017Terminated
Z-1425-2018 Class IIJAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6…The integrity of the sterile packaging is potentially compromised. 02/23/2017Terminated