Cardiac and Vascular Surgical Procedure Kits Recalled for Sterilization Assurance Issues
American Contract Systems is recalling 31,506 surgical procedure kits due to inability to confirm sterilization assurance. An internal investigation found that certain components may not have been properly sterilized.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of surgical kits used in high-risk cardiac and vascular procedures where sterilization assurance cannot be confirmed. While no illnesses or injuries have been reported, the potential for infection from non-sterilized instruments in surgical settings represents a significant risk of harm.
Plain-English summary
American Contract Systems Inc is recalling 31,506 surgical procedure kits and trays used in cardiac, vascular, and thoracic procedures. The recalled products include multiple models such as Heart Packs, Vascular Packs, Off-Pump CABG Packs, Pediatric Open Heart Packs, and related surgical supply kits across 27 different product models.
During an internal investigation, American Contract Systems determined that the sterilization rationale for certain components within these kits was not justified. As a result, the company is unable to confirm that all sterilization assurance requirements were met for some components in the kits.
The affected kits were distributed to healthcare facilities in Illinois and Louisiana.
Healthcare facilities that have received these kits should verify sterilization status before use. Contact American Contract Systems for information on returns, replacements, or verification of your specific kit lot numbers.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) MODEL/ITEM NUMBER ANCV78BC: UDI/DI 00191072235169
- Kit Lot Numbers: 42-7844511
- 42-8133811
- 42-8037211
- 42-7952411
- 42-7882011
- 2) MODEL/ITEM NUMBER ANVA82AB: UDI/DI 00191072235183
- Kit Lot Numbers: 42-8025011
- 42-8108511
- 42-7928511
- 3) MODEL/ITEM NUMBER BHOP48O: UDI/DI 00191072221490
- Kit Lot Numbers: 9207467
- 8862838
- 9140871
- 9049946
- 9007346
- 8934280
- 4) MODEL/ITEM NUMBER BHOP48P: UDI/DI 00191072234544
- Kit Lot Numbers: 9268782
- 9345847
Distribution
Distributed in 2 states:
- IL
- LA
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03
- ModerateMedtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
FDA (Devices) · 2026-06-03
- SevereMedline spinal injection kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03