Device recall: SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07…
Class II FDA enforcement event 97592. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
ASP Global, LLC. dba Anatomy Supply Partners, LLC. started this device recall on 26 Sep 2025. The firm address in the FDA record is in Austell, GA. FDA put the recall in Class II. FDA event 97592 has 24 product records. The first FDA enforcement report date is 26 Nov 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distribution US nationwide and Canada.
Recalling firm
ASP Global, LLC. dba Anatomy Supply Partners, LLC., Austell, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
24 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0544-2026 | 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. | 78000 | Class II | Ongoing | 26 Nov 2025 |
| Z-0545-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 50050 | Class II | Ongoing | 26 Nov 2025 |
| Z-0546-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 64850 | Class II | Ongoing | 26 Nov 2025 |
| Z-0547-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 27950 | Class II | Ongoing | 26 Nov 2025 |
| Z-0548-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 6600 | Class II | Ongoing | 26 Nov 2025 |
| Z-0549-2026 | AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 49000 | Class II | Ongoing | 26 Nov 2025 |
| Z-0550-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 9150 | Class II | Ongoing | 26 Nov 2025 |
| Z-0551-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 103200 | Class II | Ongoing | 26 Nov 2025 |
| Z-0552-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 6050 | Class II | Ongoing | 26 Nov 2025 |
| Z-0553-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 2100 | Class II | Ongoing | 26 Nov 2025 |
| Z-0554-2026 | SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | 1500 | Class II | Ongoing | 26 Nov 2025 |
| Z-0555-2026 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin | 2000 | Class II | Ongoing | 26 Nov 2025 |
| Z-0556-2026 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube | 209000 | Class II | Ongoing | 26 Nov 2025 |
| Z-0557-2026 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin | 397000 | Class II | Ongoing | 26 Nov 2025 |
| Z-0558-2026 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube | 352750 | Class II | Ongoing | 26 Nov 2025 |
| Z-0559-2026 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube | 77500 | Class II | Ongoing | 26 Nov 2025 |
| Z-0560-2026 | 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 | 1000 | Class II | Ongoing | 26 Nov 2025 |
| Z-0561-2026 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube | 947100 | Class II | Ongoing | 26 Nov 2025 |
| Z-0562-2026 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube | 160250 | Class II | Ongoing | 26 Nov 2025 |
| Z-0563-2026 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube | 121750 | Class II | Ongoing | 26 Nov 2025 |
| Z-0564-2026 | 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 | 620502 | Class II | Ongoing | 26 Nov 2025 |
| Z-0565-2026 | SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502 | 16920 | Class II | Ongoing | 26 Nov 2025 |
| Z-0566-2026 | Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503 | 50250 | Class II | Ongoing | 26 Nov 2025 |
| Z-0567-2026 | SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004 | 27100 | Class II | Ongoing | 26 Nov 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 24Median of the firm: 24
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 May 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL M Event 97551 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0544-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 97592. https://recallregister.com/fda/ii/97592/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distribution US nationwide and Canada.
- What quantity of product is in FDA event 97592?
- The event has 24 product records. The first record gives this quantity:
78000
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.