SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
This recall is currently active, issued November 19, 2025. It was issued by Asp Global, Llc. Dba Anatomy Supply Partners, Llc..
- Recall Initiated
- September 26, 2025
- Posted
- November 19, 2025
- Recall Number
- Z-0559-2026
- Quantity
- 77500
- Firm Location
- Austell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Distribution
Distribution US nationwide and Canada.
Lot / Code Info
Model Number: 06 0199 GTIN (Inner Pack): 30643351000322 UDI-DI: 10643351000328 All Lots produced from 31JUL2023 to 28FEB2025: 24B4199, 24E4128, 25B4098
Root Cause
Process change control
Action Taken
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 FieldActions@aspglobal.com for return authorization and disposal. e) Complete and return the Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com. For questions or assistance - contact FieldActions@aspglobal.com (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM ET