Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion
Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device that broke off inside a patient's body cavity, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports.
Plain-English summary
Stryker Sustainability Solutions is recalling the Fuhrman Pleural/Pneumopericardial Drainage Set. The recall involves 34 devices distributed in the United States to the states of Alaska, California, Wisconsin, Indiana, Florida, Oregon, New York, and North Carolina. The set consists of a pigtail catheter, access needle, dilator, wire guide, multipurpose tubing adapter, and three-way stopcock.
The recall was initiated due to complaints that the device broke off in the pleural cavity while being inserted into a patient. The affected devices are identified by Item Number G03974 and specific lot numbers including 295397U, 331621U, 374044U, 394431U, 406125U, 406131U, 410982U, 412655U, 415094U, 422060U, 519812U, 7718289U, and 838193U.
Healthcare facilities and consumers should stop using the affected devices and contact Stryker Sustainability Solutions for further instructions or a return.
The recalled product
- Product
- The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Drainage Set
- Affected units
- 34
Distribution
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