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Open, Classified

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube

FDA Recall Z-0560-2026 · Posted 2025-11-19

Recall StatusOpen, Classified
Product CodeGIO
Date Initiated2025-09-26
Product Quantity1000

Reason for Recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Firm Action

On 09/26-29/2025, ASP Global emailed an URGENT MEDICAL DEVICE RECALL Letter to customers. ASP Global, LLC, is voluntarily recalling all RAM Scientific SAFE-T-FILL products within remaining expiry. ASP Global was made aware that our contract manufacturer for the RAM Scientific SAFE-T-FILL products was issued an FDA Warning Letter citing significant violations of the Quality System requirements, including inadequate production and process controls, as well as design controls. Customers are instructed to: a) Discontinue use of the recalled products immediately. b) Quarantine any remaining inventory to prevent further use. c) If critical or abnormal test results were obtained using the affected SAFE-T-FILL products, ensure they are verified through repeat or confirmatory testing in accordance with institutional protocols (e.g., venous confirmation of abnormal pediatric screening results). d) Dispose remaining inventory in accordance with your local facility guidelines or notify ASP Global at [email protected] for return authorization and disposal. e) Complete and return the Recall Response Form to confirm receipt and actions to [email protected]. For questions or assistance - contact [email protected] (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM ET

Root Cause

Process change control

Distribution Pattern

Distribution US nationwide and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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