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.
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 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
- 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 (11)
- 22G4485
- 22K4018
- 23A4160
- 23C4340
- 23F4168
- 23F4169
- 23H4107
- 23I4055
- 23J4039
- 24E4129
- 24F4189
Distribution
Distributed nationwide across the United States.
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