Large volume capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 352,750 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with balanced heparin, 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 Plastic Blood Gas Capillary Tubes, 230 microlitres, prepared with balanced heparin, model 06 0187, from ASP Global doing business as Anatomy Supply Partners, are being recalled. The product is a clear plastic capillary blood collection tube.
The recall follows products manufactured under an inadequate quality system, including unvalidated manufacturing processes.
The recall covers 352,750 units carrying UDI-DI 10643351000281, 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 Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
- 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 (6)
- 24A4108
- 24B4197
- 24D4023
- 24E4137
- 24E4278
- 24L4004
Distribution
Distributed nationwide across the United States.
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