Z-1297-2018Class II

Large Volume Abdominal Paracentesis Kit

Name: Z-1297-2018 Large Volume Abdominal Paracentesis Kit
Creator: Arrow International Inc
Published: 2017-10-24
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-10-24 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Large Volume Abdominal Paracentesis Kit on 2017-10-24. FDA classified it as Class II and gives the reason as "Product packaging may not be completely sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1297-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Posted: 2018-04-03
Terminated: 2020-04-17
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Large Volume Abdominal Paracentesis Kit
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Product packaging may not be completely sealed.
Root cause tag: design
FDA root cause: Component design/selection
Action: On October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990
Quantity in commerce: 30,577 eaches
Distribution: Nationally
Product codes and lots: AK 00376

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1297-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1297-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03
Z-1298-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03
Z-1299-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03

Product code KDD

K874063Class IEnteron Abdominal Paracentesis TrayEndovations / cleared 1987-12-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)