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ASP Global, LLC

Austell, GA, US

ASP Global, LLC appears in FDA device records in Austell, GA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 25 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
25
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to ASP Global, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • ASP Global, LLC. dba Anatomy Supply Partners, LLC.enforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for ASP Global, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30048246013004824601ASP Global, LLC7800 Third Flag Pkwy, Austell, GA 30168 US2026and 50 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0567-2026SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0566-2026Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0565-2026SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0564-2026SAFE-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 tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0563-2026SAFE-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 tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0562-2026SAFE-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 tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0561-2026SAFE-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 tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0560-2026SAFE-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 tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0559-2026SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0558-2026SAFE-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 tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0557-2026SAFE-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 HeparinDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0556-2026SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tubeDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0555-2026SAFE-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 HeparinDue to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0554-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0553-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0552-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0551-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0550-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0549-2026AFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0548-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0547-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0546-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0545-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0544-2026SAFE-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.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.Class IIOpen, Classified
Z-0372-2026SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection, 300 L Prepared with Dipotassium EDTA Purple, Model: 07 7053; SAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Purple, Model: 07 7056; SAFE-T-FILL Micro Capillary Blood Collection, 200 L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058 SAFE-T-FILL End-to-End Capillary Tubes, 30 L; Plastic, Prepared with EDTA Dipotassium Model: 06 0910All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain