Z-0175-2026Class II

Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X...

Name: Z-0175-2026 Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X...
Creator: American Contract Systems Inc.
Published: 2025-09-04
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2025-09-04 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems Inc. began a recall of Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY... on 2025-09-04. FDA classified it as Class II and gives the reason as "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to...". 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-0175-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-04
Posted: 2025-10-16
Recalling firm: American Contract Systems, Inc.
Product: Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
Product code: OES Cardiac Catheterization Kit
Reason for recall: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
Quantity in commerce: 32,433 total
Distribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Product codes and lots: AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68194176 68194179 68194182 68194190 Lot 8526511 Bag serial numbers 68873157 68874410; EVLH67F UDI-DI 191072232380 Lot 8211011 Bag serial number N/A Lot 8367311 Bag serial number 68570438; FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376; IHCC03X UDI-DI 191072226273 Lot 80111 Bag serial number N/A Lot 8085711 Bag serial numbers 47506640 47506761; TNCC02AD UDI-DI 191072212757 Lot 7970911 Bag serial number N/A Lot 8045911 Bag serial number 47503192 Lot 8426711 Bag serial number 47886615; UICC27AG UDI-DI 191072231307 Lot 8085511 Bag serial number N/A Lot 8167611 Bag serial number 68194108; UIRD89AH UDI-DI 191072231314 Lot 8068111 Bag serial number 47499672 47499908 * if Bag serial number is "n/a", then all of that lot is affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0175-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0171-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0172-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0173-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0174-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0175-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0176-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0177-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0178-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0179-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0180-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0181-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0182-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0183-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0184-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0185-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0186-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0187-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16

Product code OES

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)