Sodium fluoride microtubes recalled over an inadequate quality system
ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.
What this means for you
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 Micro Capillary Blood Collection tubes, 200 microlitres, prepared with sodium fluoride, gray, model 07 7340, from ASP Global doing business as Anatomy Supply Partners, are being recalled. The SAFE-T-FILL system is used to draw capillary blood.
The recall follows products manufactured under an inadequate quality system, including unvalidated manufacturing processes.
The recall covers 2,100 units carrying UDI-DI 10643351000137, 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 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.
- Manufacturer
- ASP Global, LLC. dba Anatomy Supply Partners, LLC.
- Hazard
- quality-system
- unvalidated-process
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 (1)
- 24K4372
Distribution
Distributed nationwide across the United States.
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