Capillary end caps recalled over an inadequate quality system
ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a quality system and process validation finding rather than an identified defect or reported harm.
Plain-English summary
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries, fitting outer diameters of 1.6 to 2.1 mm, model 06 0402, from ASP Global doing business as Anatomy Supply Partners, are being recalled.
The recall follows products manufactured under an inadequate quality system, including unvalidated manufacturing processes.
The recall covers 620,502 units carrying UDI-DI 10643351000342, across all lots produced from a stated start date. The product was distributed nationwide in the United States and in Canada. The FDA has classified the action as Class II.
The enforcement record cites the quality system finding without describing a device defect or health consequence, and reports no injuries. Laboratories holding affected stock should follow the firm's instructions.
The recalled product
- 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
- Affected units
- 620,502
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 22G4485
- 22K4018
- 23A4160
- 23C4340
- 23F4168
- 23F4169
- 23H4107
- 23I4055
- 23J4039
- 24E4129
- 24F4189
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by ASP Global, LLC. dba Anatomy Supply Partners, LLC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · ASP Global, LLC. dba Anatomy Supply Partners, LLC.
See all →- ModerateLarger sodium heparin capillary tubes recalled over unvalidated manufacturing processes
FDA (Devices) · 2025-11-26
- ModerateThree hundred microlitre clot activator tubes recalled over quality system findings
FDA (Devices) · 2025-11-26
- ModerateAmber clot activator microtubes recalled over an inadequate quality system
FDA (Devices) · 2025-11-26
- ModerateSerum separator microtubes recalled over unvalidated manufacturing processes
FDA (Devices) · 2025-11-26
- ModerateSodium heparin capillary tubes recalled over an inadequate quality system
FDA (Devices) · 2025-11-26
Same hazard · quality system
See all →- ModerateClot activator microtubes recalled over an inadequate quality system
FDA (Devices) · 2025-11-26
- ModeratePlasma separator microtubes recalled over an inadequate quality system
FDA (Devices) · 2025-11-26
Similar recalls
- HighCapillary blood tubes recalled for causing false positive lead test results
FDA (Devices) · 2025-11-05
- HighSiemens Healthcare Recalls Capillary Caps Due to Breakage Risk
FDA (Devices) · 2015-03-18
- HighCapillary tubes recalled over a positive bias in potassium results
FDA (Devices) · 2026-02-25
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- LowAbbVie Recalls Ultane Sevoflurane Due to Defective Container Caps
FDA (Drugs) · 2018-02-07