Cook Inc. Recalls Pneumothorax Trays Due to Sterility Compromise Risk
Cook Inc. is recalling 41 units of Pneumothorax Trays because a perforation line may be positioned over the sterile area, potentially compromising device sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard is a potential compromise of sterility due to a packaging/labeling defect (perforation line placement), with no reported illnesses or injuries in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cook Inc. is recalling 41 units of Pneumothorax Trays, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537, Lot 9850522. The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
The recall is due to a manufacturing defect where the Lidstock perforation line may be located over the sterile area of the tray instead of on the lip. This positioning error potentially compromises the sterility of the device.
The affected units were distributed nationwide in the states of California, Florida, Indiana, Michigan, Montana, North Carolina, New York, and Ohio. Users should stop using the affected trays and contact Cook Inc. for further instructions.
The recalled product
- Product
- Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Surgical Trays
- Affected units
- 41
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)
- Lot 9850522
Distribution
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