B. Braun Recalls Pain Management Trays with Foreign Matter
B. Braun Medical is recalling 460 Pain Management Trays containing 22GA SafetyGlide Needles due to the presence of loose polypropylene foreign matter.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard involves foreign matter that was tested for biocompatibility, fitting the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
B. Braun Medical, Inc. (BBMI) has initiated a recall of 460 units of Pain Management Trays (Product Catalog Number 560602) distributed nationwide in the United States. The recall is due to the presence of loose polypropylene foreign matter in the 22GA 1-1/2in SafetyGlide Needles contained within these kits. This foreign matter exceeded release specifications.
The foreign matter has been identified as a product hub material. According to the recall notice, this material was tested for biocompatibility per ISO 10993 during the product development process. The affected products are used for local anesthesia of the skin prior to the insertion of regional anesthesia needles.
The recall number is Z-0575-2018. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 460
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)
- 0061522622. 0061537909.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by B. Braun Medical, Inc. 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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