Z-0931-2023Class II

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Name: Z-0931-2023 Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Creator: Stradis Healthcare
Published: 2022-12-15
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2022-12-15 / Open, Classified / root cause: manufacturing process

FDA source

Stradis Healthcare began a recall of Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile on 2022-12-15. FDA classified it as Class II and gives the reason as "Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0931-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-15
Posted: 2023-01-11
Recalling firm: Gyn-Disposables, Inc.
Product: Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Product code: PPG Urinary Drainage Collection Kit
Reason for recall: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
Quantity in commerce: 920 units
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Product codes and lots: a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0932-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0933-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0934-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0935-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0936-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0937-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0938-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0939-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0940-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0941-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0942-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0943-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0944-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0945-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0946-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0947-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11
Z-0948-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-11

Product code PPG

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)