Capillary magnetic rings recalled over unvalidated manufacturing processes
ASP Global is recalling 16,920 SAFE-T-FILL magnetic rings for blood gas capillaries over an inadequate quality system with unvalidated 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 Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, model 07 9502, 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 16,920 units carrying UDI-DI 10643351000359, 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 Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
- Affected units
- 16,920
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 (7)
- 22F4084
- 22F4109
- 23A4170
- 23H4154
- 23H4228
- 23I4057
- 23I4058
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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