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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

SAFE-T-FILL Blood Gas Capillary Accessories Recalled for Quality Issues

Agency Publication Date: November 19, 2025
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Summary

Anatomy Supply Partners, LLC is recalling 714,772 units of SAFE-T-FILL blood collection tube accessories, including end caps, magnetic rings, mixing fleas, and tube extenders. These products were manufactured under an inadequate quality system with unvalidated manufacturing processes, which means their safety and performance standards cannot be confirmed. The affected components, used in medical testing for blood gas capillaries, were produced between August 2020 and February 2025.

Risk

Because these devices were manufactured using unvalidated processes, there is a risk that the components may not perform as intended. This could potentially lead to device failure during specimen collection or inaccurate medical test results, though no specific injuries have been reported.

What You Should Do

  1. This recall affects SAFE-T-FILL brand blood collection accessories, including End Caps (Model 06 0402), Magnetic Rings (Model 07 9502), Mixing Fleas (Model 07 9503), and Micro Collection Tube Extenders (Model 09 1004).
  2. Identify if you have these products by checking the model number and lot codes printed on the individual pack or inner carton labels. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries
Variants: Fits outer diameter 1.6 - 2.1mm
Model / REF:
06 0402
Lot Numbers:
22A4541
22G4485
22K4018
23A4160
23C4340
23F4168
23F4169
23H4107
23I4055
23J4039
24E4129
24F4189
UDI:
10643351000342
GTIN:
30643351000346

Produced from 01AUG2020 to 28FEB2025.

Product: SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries
Model / REF:
07 9502
Lot Numbers:
21G4272
22F4084
22F4109
23A4170
23H4154
23H4228
23I4057
23I4058
UDI:
10643351000359
GTIN:
30643351000353

Produced from 01JUN2022 to 28FEB2025.

Product: Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries
Model / REF:
07 9503
Lot Numbers:
22B4465
22E4465
22I4072
23B4158
23C4345
23F4176
23H4109
23I4060
24D4021
24E4130
24E4131
UDI:
10643351000366
GTIN:
30643351000360

Produced from 01FEB2023 to 28FEB2025.

Product: SAFE-T-FILL Micro Collection Tube Extender
Model / REF:
09 1004
Lot Numbers:
21D4585
22E4059
22J4037
23I4016
23J4029
UDI:
10643351000229
GTIN:
30643351000223

Produced from 01AUG2020 to 28FEB2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97592
Status: Active
Manufacturer: ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sold By: Medical distributors; Anatomy Supply Partners
Manufactured In: United States
Units Affected: 4 products (620502; 16920; 50250; 27100)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.