Stryker AccuPlace Drace Stereotaxic Needle Guide Recalled for Packaging Sterility Risk
Stryker is recalling AccuPlace Drace Stereotaxic Needle Guides because packaging defects may breach sterility. The recall covers 5,800 units distributed nationwide.
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, and the hazard is a potential breach in sterility due to packaging damage. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling the AccuPlace Drace Stereotaxic Needle Guide, a medical device used to assist with inserting a needle at a predetermined angle for computer tomography. The recall involves 5,800 units of the product.
The recall was initiated after an evaluation of the product packaging determined that there is a potential for the product to cause damage to the packaging, which could create a possible breach in sterility. The affected devices were distributed nationwide, including in Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.
The devices are identified by product number 50000. Units distributed between May 1, 2013, and May 31, 2014, are labeled with Inrad's name and product number. Units distributed between June 20, 2014, and December 3, 2015, are labeled with Stryker's name and product number. Specific lot numbers include 61305001, 61310001, 61312001, and 61404006. Healthcare facilities should stop using the affected devices and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 5,800
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 (3)
- 50000 Lot numbers: 61305001
- 61310001
- 61312001
Distribution
Part of a larger recall action
This product is one of 4 recalled by Stryker Instruments Div. of Stryker Corporation 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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