Z-1426-2018Class II

Thoracentesis/ Paracentesis Kit 10/CS; STERILE

Name: Z-1426-2018 Thoracentesis/ Paracentesis Kit 10/CS; STERILE
Creator: Carefusion 2200 Inc
Published: 2017-02-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-02-23 / Terminated / root cause: packaging

FDA source

Carefusion 2200 Inc began a recall of Thoracentesis/ Paracentesis Kit 10/CS; STERILE on 2017-02-23. FDA classified it as Class II and gives the reason as "The integrity of the sterile packaging is potentially compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1426-2018
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Posted: 2018-04-18
Terminated: 2019-07-09
Recalling firm: Medtronic, Inc.
Product: Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
Product code: FSH Tray, Surgical, Needle
Reason for recall: The integrity of the sterile packaging is potentially compromised.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 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
Product codes and lots: Product Code: TPK1001 / LOT 0000837811, 0000842215, 0000840336, 0000851185

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1426-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1421-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-18
Z-1422-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-18
Z-1423-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-18
Z-1424-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-18
Z-1425-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-18
Z-1426-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-18

Product code FSH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)