Tube, Collection, Capillary Blood
FDA product code GIO · Class I (low risk) · 21 CFR 864.6150 · Hematology
22510(k) clearances
0PMA approvals
22recalls
Manufacturers
- American Dade 5
- Sherwood Medical Co. 3
- Medical Technomics, Ltd. 3
- Helps Products, Inc. 2
- Sherwood Medical Industries 1
- Abco Dealers, Inc. 1
- Corning Medical & Scientific 1
- Ventrex Laboratories, Inc. 1
- Safe-Tec Clinical Products, Inc. 1
- Coeur Laboratories, Inc. 1
- Medical Products Search, Inc. 1
- Humagen, Inc. 1
- Innovative Medical Technologies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972969 | Quick-Draw Capillary Whole Blood Collection SystemGIO · Traditional | Innovative Medical Technologies, Inc. | 09/22/1997SE |
| K941291 | Monoject Samplette Separator TubeGIO · Traditional | Sherwood Medical Co. | 10/27/1994SE |
| K894851 | Tru-TraxGIO · Traditional | Humagen, Inc. | 09/29/1989SE |
| K885324 | Hema(Pro)Tec(Tion)GIO · Traditional | Medical Products Search, Inc. | 02/17/1989SE |
| K885138 | Capillary Tube, Blood CollectionGIO · Traditional | Coeur Laboratories, Inc. | 02/07/1989SE |
| K884623 | Safe-Tec Capillary Blood Collection TubeGIO · Traditional | Safe-Tec Clinical Products, Inc. | 12/01/1988SE |
| K881262 | Caraway Tubes, Heparin and PlainGIO · Traditional | Helps Products, Inc. | 05/06/1988SE |
| K881187 | Natelson Tubes, Heparin and PlainGIO · Traditional | Helps Products, Inc. | 05/06/1988SE |
| K875061 | Monoject Samplette Amber Capillary Serum SeparatorGIO · Traditional | Sherwood Medical Co. | 01/12/1988SE |
| K873647 | Ventrescreen Capillary Blood Collection TubeGIO · Traditional | Ventrex Laboratories, Inc. | 10/20/1987SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | Corning Medical & Scientific | 03/25/1985SE |
| K843608 | Capillary Blood Collection TubeGIO · Traditional | Medical Technomics, Ltd. | 11/30/1984SE |
| K843892 | Micro Hematocrit Capillary TubesGIO · Traditional | Abco Dealers, Inc. | 11/13/1984SE |
| K843362 | RingcapsGIO · Traditional | Medical Technomics, Ltd. | 09/21/1984SE |
| K843361 | MinicapsGIO · Traditional | Medical Technomics, Ltd. | 09/21/1984SE |
| K832578 | Monojet Samplette AdaptersGIO · Traditional | Sherwood Medical Co. | 08/31/1983SE |
| K812970 | S/P Capillary Tubes, Heparinized (3A)GIO · Traditional | American Dade | 11/06/1981SE |
| K812969 | S/P Capillary Tubes, Heparinized (2A)GIO · Traditional | American Dade | 11/06/1981SE |
| K812923 | S/P Sure-Cap NGIO · Traditional | American Dade | 11/06/1981SE |
| K812922 | S/P Sure-Cap CGIO · Traditional | American Dade | 11/06/1981SE |
| K812921 | S/P Sure-CapGIO · Traditional | American Dade | 11/06/1981SE |
| K770981 | Lancer Capillary Blood Serum SeparatorGIO · Traditional | Sherwood Medical Industries | 07/11/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0567-2026 Class II | SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0566-2026 Class II | Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0565-2026 Class II | SAFE-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… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0564-2026 Class II | SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 -…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0563-2026 Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Balanced Heparin…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0562-2026 Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 L; Prepared with Sodium Heparin…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0561-2026 Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Sodium Heparin…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0560-2026 Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Sodium Heparin…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0559-2026 Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Untreated. Model 06 0199 Product…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0558-2026 Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 L; Prepared with Balanced Heparin…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0557-2026 Class II | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Balanced Heparin…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0556-2026 Class II | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Untreated, Blue Markings…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-0555-2026 Class II | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Plastic, Ammonium Heparinized, Red…Due to products manufactured under an inadequate quality system to include unvalidated manufacturing… | ASP Global, LLC. dba Anatomy Supply… | 09/26/2025Open, Classified |
| Z-2249-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | Radiometer Medical ApS | 03/17/2020Terminated |
| Z-2248-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | Radiometer Medical ApS | 03/17/2020Terminated |
| Z-2247-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | Radiometer Medical ApS | 03/17/2020Terminated |
| Z-0211-2009 | Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID. Catalog number 270-106.…presence of OSCS contaminant | Drummond Scientific Co | 08/01/2008Terminated |
| Z-0210-2009 | Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107.…presence of OSCS contaminant | Drummond Scientific Co | 08/01/2008Terminated |
| Z-0209-2009 | Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample…presence of OSCS contaminant | Drummond Scientific Co | 08/01/2008Terminated |
| Z-0208-2009 | Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive…presence of OSCS contaminant | Drummond Scientific Co | 08/01/2008Terminated |
| Z-2152-2008 | Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app.…This lot of Heparinized Capillary Tubes contain contaminated lithium heparin. | Opti Medical Systems Inc | 05/08/2008Terminated |
| Z-0975-2007 | SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250…The clinitubes are not able to be filled due to contamination with silicone during production. | Radiometer America Inc | 06/22/2006Terminated |