HIGH

American Contract Systems Recalling 32,433 UDPG88W PICC G-TUBE Pack in 2025 Recall

American Contract Systems recalled 32,433 UDPG88W PICC G-TUBE PACK medical kits nationwide after a nonconformance in Ethylene Oxide sterilization led to re-gassing. The devices have not been validated for multiple sterilization cycles. Healthcare providers and patients should stop using the kit immediately and follow recall instructions.

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

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

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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. 1. Check kit packaging for UDPG88W and UDI-DI 191072216359.
  2. 2. Verify lot number 7935611 and bag serial number; if serial is N/A, the entire lot is affected.
  3. 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.

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
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypePICC G-Tube Pack
Sold At
Multiple Retailers

Product Details

Model Numbers
UDPG88W UDI-DI 191072216359 lot 7935611 bag serial number N/A
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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