Z-0544-2026Class II
SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog...
ASP Global, LLC / initiated 2025-09-26 / Open, Classified / root cause: manufacturing process
ASP Global, LLC. dba Anatomy Supply Partners, LLC. began a recall of SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL... on . FDA classified it as Class II and gives the reason as "Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0544-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- ASP Global, LLC
- Product
- SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
- Product code
- JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
- Reason for recall
- Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Root cause tag
- manufacturing process
- FDA root cause
- Process change control
- 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
- Quantity in commerce
- 78000
- Distribution
- Distribution US nationwide and Canada.
- Product codes and lots
- Model Number: 07 6101 GTIN (Inner Pack): 10643351000083 UDI-DI: 10643351000083 All Lots produced from 01AUG2023 to 28FEB2025: 23H4112, 23I4019, 23J4032, 24B4189, 24H4122, 24I4319, 24J4236, 24L4003
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0544-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0545-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0546-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0547-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0548-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0549-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0550-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0551-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0552-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0553-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0554-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0555-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0556-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0557-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0558-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0559-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0560-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0561-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0562-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0563-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0564-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0565-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0566-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0567-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.