Z-0564-2026Class II
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402...
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 End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary... 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-0564-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- ASP Global, LLC
- Product
- SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
- Product code
- GIO Tube, Collection, Capillary Blood
- 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
- 620502
- Distribution
- Distribution US nationwide and Canada.
- Product codes and lots
- Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189
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 |
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