American Contract Systems, Inc. recalls Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software…
Sterility assurance with procedure trays
Read the official notice →- Date
- 2025-04-02
- Country
- United States
- Brand
- American Contract Systems
- Product
- Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A…
- Classification
- Class II
- Units
- US: AZ OUS: None
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More American Contract Systems recalls
- 2025-10-22
USAmerican Contract Systems Inc. recalls Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991…
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…
FDA · DeviceAmerican Contract Systems Inc.US Nationwide distribution in the states of SD, IA, MN, WA, IL.Official notice →- 2025-09-03
- US
American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL…
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS…
- 2025-06-18
- US
American Contract Systems, Inc. recalls LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model:…
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the state of CO.Official notice → - 2025-03-26
- US
American Contract Systems Inc recalls CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
- US
American Contract Systems Inc recalls MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
FDA · DeviceAmerican Contract Systems IncUS Nationwide distribution in the state of OH.Official notice → - 2024-10-02
- US
American Contract Systems, Inc. recalls Pacemaker, COPM11B; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of MO, MN, MA, OH, NE.Official notice →
Other drugs & medical recalls in the United States
- 2025-04-02
- US
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP,…
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of California, Colorado, and Missouri.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *,…
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of The Netherlands,…Official notice → - US
St. Jude Medical recalls CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model…
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient…
FDA · DeviceSt. Jude MedicalU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to…
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Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- US
Premier Dental Products Co recalls Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
The hardness not meeting the material specification and may cause the diamond bur to bend.
FDA · DevicePremier Dental Products CoUS Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.Official notice →