Z-1047-2016Class II

Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for...

Name: Z-1047-2016 Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for...
Creator: Gi Supply
Published: 2016-01-28
License: https://open.fda.gov/license/

Gi Supply / initiated 2016-01-28 / Terminated / root cause: manufacturing process

FDA source

Gi Supply began a recall of Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag... on 2016-01-28. FDA classified it as Class II and gives the reason as "Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1047-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-28
Posted: 2016-03-04
Terminated: 2016-12-07
Recalling firm: Gi Supply
Product: Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04
Product code: LRO General Surgery Tray
Reason for recall: Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The customers will be made aware of the defect, including pictures provided and are instructed to inspect the RP Bags in the kit prior to use. If the pinch clamp is missing, the customer is instructed to discard the RP Bag and use the sterile RP Bag replacements provided.
Quantity in commerce: 390 Kits
Distribution: Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.
Product codes and lots: Lot #: 61442434 Expiration Date: 2018/04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1047-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1047-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-04

Product code LRO

K970187Class IIRunyon Large Volume Paracentesis KitGi Supply / cleared 1997-02-14

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)