Plasma separator microtubes recalled over an inadequate quality system
ASP Global is recalling 49,000 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin and plasma separator gel, 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 lithium heparin and plasma separator gel, green, model 07 7220, 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 49,000 units carrying UDI-DI 10643351000090, 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
- AFE-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 th
- Affected units
- 49,000
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 (6)
- 23I4054
- 23J4036
- 24A4107
- 24H4123
- 24I4324
- 24L4007
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.
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