Stryker 6376 M-1 Cot Fastener Recalled for Missing Manual Warnings
Stryker is recalling 59 M-1 Cot Fasteners distributed to the Netherlands because their operation and maintenance manuals are missing warnings and contain incorrect information.
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, but the source text explicitly states the issue is missing warnings and incorrect information in manuals without reporting any illnesses or injuries. Per the rubric, a Class II recall without hospitalization reports or significant injury reports, where the hazard is primarily documentation-related, aligns with a Moderate severity score.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 59 units of the 6376 M-1 Cot Fastener, catalog number 6376000000. The affected units were distributed to the Netherlands and are identified by serial numbers ranging from 170740300 to 170740358.
The recall was initiated because the Operations Manual and Maintenance Manual for these devices are missing various warnings and contain incorrect information. This documentation deficiency could potentially impact the safe use or maintenance of the medical device.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the recall.
The recalled product
- Product
- 6376 M-1 Cot Fastener, catalog no. 6376000000
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 59
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Stryker Medical Division 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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