Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by a documentation issue where the instructions for use do not support specific sterilization methods, which fits the rubric criteria for Low severity (documentation issues).
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This documentation issue affects the ability to properly sterilize the devices using these specific methods.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which al
- Manufacturer
- Stryker Endoscopy
- Hazard
- Affected units
- 180,573
Distribution
Part of a larger recall action
This product is one of 207 recalled by Stryker Endoscopy 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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