Smiths Medical Recalls Graseby 3300 Pumps Due to Key Mismatch
Smiths Medical is recalling 77 Graseby 3300 syringe pumps and accessories because the supplied lock and key may not match the standard key.
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. The hazard involves a mechanical mismatch (lock and key) which is a functional defect but does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Smiths Medical ASD Inc. is recalling 77 units of the Graseby 3300 Pump and Graseby 3000 Series Pump Accessories. These are patient-controlled syringe pumps used for infusion. The recall is due to a defect where the lock and key supplied with the devices do not match the standard Graseby 3300 key in certain cases.
The affected products were distributed worldwide to Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland. The specific models involved are 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451. The recall covers specific serial numbers listed in the agency's official documentation.
Healthcare facilities and users should stop using the affected pumps and contact Smiths Medical ASD Inc. for instructions on how to resolve the issue. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Syringe Pumps
- Hazard
- Affected units
- 77
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 (20)
- Model: 0128-0001
- 0128-0025
- 0128-0135
- 0128-0136
- and 0128-0451 Lot/Serial #'s: 1074
- 8305
- 8718
- 11325
- 11540
- 16230
- 32982
- 34076
- 42678
- 52734
- 55337
- 60959
- 60965
- 64104
- 67638
- 68079
Distribution
Distribution scope not specified by the agency.
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