Various Angiography packs/trays
FDA Device Recall #Z-1689-2022 — Class II — June 16, 2022
Recall Summary
| Recall Number | Z-1689-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 16, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Contract Systems, Inc. |
| Location | Kansas City, MO |
| Product Type | Devices |
| Quantity | 57 units |
Product Description
Various Angiography packs/trays
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Distribution Pattern
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Lot / Code Information
Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number: 1) LSRARTDATANGA,2105051, 884211, 44136929 2) LSRANGIRM21G,2105111, 874211, 63991913 3) LSRCFHANGD,2106031, 854211, 14887381 4) LSRARTDATANGA,2107102, 821211, 44256256 5) LSRARTDATANGA,2107102, 821211, 44256255 6) LSRARTDATANGA,2110011, 742211, 44373255 7) LSRARTDATANGA,2110011, 742211, 44373260 8) LMAN19U,2106292, 824211, 64169682 9) IHAN02S,2108111, 782211, 64190032 10) ANCA80AG,2109161, 743211, 64222813 11) SLPC34,2104022, 908211, 44127417-005 12) MHHY51F,2104151, 895211, 63978560-006 13) CXAN39N,2105072, 873211, 14875221-004 14) FHAG11X,2105072, 873211, 44111418-005 15) MHIR99AF,2105132, 868211, 63958625-006 16) BHAN91L,2105211, 860211, 44107976-005 17) ANCA80AG,2105212, 860211, 63956879-006 18) UDIN23AB,2105253, 855211, 63955146-006 19) SLPC34H,2106011, 853211, 44130251-005 20) SLPC34H,2106232, 827211, 43995487-005 21) SLPC34H,2106232, 827211, 43995488-005 22) FHAG11X,2106252, 825211, 43993760-005 23) FHAG11X,2106252, 825211, 44247863-005 24) SLPC34H,2107082, 817211, 44245946-005 25) CXAN39N,2107261, 793211, 15007653-004 26) CXAN39N,2107261, 793211, 15007652-004 27) UDCO10A,2107292, 790211, 64109977-006 28) BHAN91L,2107302, 789211, 44235082-005 29) FHAG11X,2108102, 778211, 44240799-005 30) FHAG11X,2108102, 778211, 44240798-005 31) BHAN91,2108131, 776211, 44240114-005 32) SLPC34H,2108242, 764211, 44315271-005 33) SLPC34H,2108242, 764211, 44315270-005 34) BHAN91L,2109101, 748211, 44320300-005 35) FHAG11X,2109151, 742211, 44318761-005 36) SLPC34H,2109232, 734211, 44316981-005 37) NCAG62G,2105252, 860211, 64063801-006 38) TMAN84F,2106162, 838211, 64044558-006 39) TMAN84F,2106162, 838211, 64044569-006 40) GSAN26D,2108131, 778211, 44216057-005 41) GSAN26D,2108131, 778211, 44215917-005 42) CGSP34G,2108271, 764211, 44336891-005 43) CGSP34G,2108271, 764211, 44336906-005 44) CGSP34G,2108271, 764211, 44336889-005 45) CGSP34G,2108271, 764211, 44336890-005 46) GSAN26D,2109271, 735211, 44353838-005 47) GSAN26D,2109271, 735211, 44353837-005 48) GSAN26D,2109271, 735211, 44353836-005 49) SJAR31F,2104211, 894211, 14702002-004 50) SJMY36D,2105241, 859211, 14894016-004 51) WHAI40C,2106071, 844211, 64133103-006 52) SSAR20D,2106151, 838211, 14893801-004 53) SJAR31F,2107191, 805211, 15031953-004 54) MPRM25D,2107261, 797211, 15028609-004 55) SJAR31F,2108231, 769211, 15025673-004 56) SJAR31F,2109141, 743211, 15023697-004 57) WHAI40C,2109241, 735211, 64135103-006
Other Recalls from American Contract Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1916-2025 | Class II | LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREM... | Apr 21, 2025 |
| Z-1426-2025 | Class II | Brand Name: Banner University Med Ctr. Produ... | Jan 31, 2025 |
| Z-1425-2025 | Class II | Brand Name: Banner Health Systems Product Name... | Jan 31, 2025 |
| Z-1424-2025 | Class II | Brand Name: Banner Health Systems Product Name... | Jan 31, 2025 |
| Z-3244-2024 | Class II | Pacemaker, COPM11B; Medical convenience kit | Aug 7, 2024 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.