Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- American Contract Systems
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- American Contract Systems
- Product type
- PICC G-Tube Pack
- Model numbers
- UDPG88W UDI-DI 191072216359 lot 7935611 bag serial number N/A
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Medical convenience kits used in procedures involving PICC lines and G tubes. These kits are intended to streamline preparation and care in clinical settings.
Why This Is Dangerous
Re-gassing after EO sterilization means the product may have undergone more than one sterilization cycle without validation. This creates uncertainty about sterility, quality, and effectiveness.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use of affected lots. The recall affects 32,433 units and spans several states, potentially impacting patient procedures and sterilization workflows.
Practical Guidance
How to identify if yours is affected
- 1. Check kit packaging for UDPG88W and UDI-DI 191072216359.
- 2. Verify lot number 7935611 and bag serial number; if serial is N/A, the entire lot is affected.
- 3. Compare with FDA recall notice for confirmation.
Where to find product info
Recall notice and product identifiers are available via the FDA enforcement recall page linked in the notice.
What timeline to expect
Remedy processing generally occurs within weeks to months, depending on logistics and replacement availability.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to local health authorities or the FDA recall program if needed.
How to prevent similar issues
- In future purchases, verify sterilization validation and reuse policies for reusable medical kits.
- Request documentation of EO sterilization cycles and re-gassing checks from suppliers.
- Procure from established distributors with recall support.
Documentation advice
Keep the recall notice, packaging, lot codes, and any correspondence with the manufacturer for records.
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Product Details
Model: UDPG88W UDI-DI 191072216359 lot 7935611 bag serial number N/A. Sold across the United States in SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,433 total units recalled
- EO sterilization nonconformance led to re-gassing
- Units distributed nationwide in SD, IA, MN, WA, IL
- Re-gassed devices not validated for multiple sterilization cycles
- Recall status is ACTIVE
- Hazard level HIGH
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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