Atrium Medical Recalls PleuraGuide Chest Tube Kits Due to Missing Instructions
Atrium Medical Corporation is recalling 6,516 PleuraGuide Disposable Chest Tube Kits because individual component instructions for use are missing.
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 explicitly states the issue is missing documentation (IFUs) and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Atrium Medical Corporation is recalling 6,516 units of the PleuraGuide Disposable Chest Tube Kit, product codes 17100, 17150, and 17200. The product is indicated to assist with the insertion of thoracic catheters. The recall was initiated because the individual component instructions for use (IFUs) are not included with the kit.
The affected products were distributed nationwide. The recall is classified as Class II by the FDA. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare providers and consumers should check their inventory for the specific part numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Atrium Medical Corporation or the distributor.
The recalled product
- Product
- PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 6,516
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 (20)
- Part Number: 17100: 10734588
- 10734583
- 10728237
- 10728236
- 10728235
- 10728234
- 10736244
- 10736243
- 10736242
- 10736238
- 10734590
- 10734589
- 10736245
- 10852352
- 10847222
- 10847218
- 10842301
- 10842299
- 10842297
- 10840114
Distribution
Distributed nationwide across the United States.
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