Z-2483-2018Class II

Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of...

Name: Z-2483-2018 Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of...
Creator: Cardinal Health 200, LLC
Published: 2018-02-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-02-20 / Terminated / root cause: packaging

FDA source

Cardinal Health 200, LLC began a recall of Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine... on 2018-02-20. FDA classified it as Class II and gives the reason as "A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit". 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-2483-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-20
Posted: 2018-07-18
Terminated: 2019-11-04
Recalling firm: Medtronic, Inc.
Product: Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.
Product code: LRP Tray, Surgical
Reason for recall: A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
Root cause tag: packaging
FDA root cause: Packaging
Action: Cardinal Health notified customers via Fed Ex overnight, on about 02/21/2018. The URGENT PRODUCT RECALL letter instructed customers to: 1) Inspect your inventory for the affected product code and lot number; 2)Segregate and quarantine all product on hand; 3) Return enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined; 4) Notify any customers to whom you may have distributed product affected by this recall; 5)Contact Customer Service at 800-964-5227 to arrange return and credit. Customers were also instructed to return any affected kit on site.
Quantity in commerce: 8,928 kits total
Distribution: US Nationwide Distribution in the states of California.
Product codes and lots: Product Code SP4692448A (Lot Numbers 820354, 821943, 826374, 833181). Product Code SP4692448B (Lot Number 849841, 855450).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2483-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2480-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2481-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2482-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2483-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18

Product code LRP

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