Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements
Instrumed International is recalling 71 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.
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, but the source text indicates the action is to add caution statements to the Instructions For Use rather than addressing a reported injury or defect, aligning with the rubric for moderate severity.
Plain-English summary
Instrumed International, Inc. is recalling 71 reusable laparoscopic instruments. These instruments are packaged as non-sterile and are intended for use by qualified physicians in diagnostic and therapeutic laparoscopic or urologic procedures. The recall involves specific item numbers and lot numbers, including Instrumed Item No. 250-09010 (Lot 070411) and Item No. 250-09040 (Lots 010211, 040411).
The recall is being conducted to add additional caution statements to the Instructions For Use for monopolar electrodes. The new statements specify that the operation voltage of the HF generator must not exceed 650 peak voltage to avoid tissue carbonation. Additionally, the statements clarify that the useful life of the product is less than or equal to 50 cycles and less than or equal to 2 years.
The affected instruments were distributed nationwide in the United States, including in states such as Alabama, Arizona, California, Florida, New York, and Texas. Healthcare facilities and users should stop using the affected instruments and contact the recalling firm for further instructions regarding the updated documentation.
The recalled product
- Product
- Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 71
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 (7)
- 1) Instrumed Item No.: 250-09010
- Phoenix Instruments Catalog Code: 190-9523
- Lot Number: 070411
- 2) Instrumed Item No.: 250-09040
- Phoenix Instruments Catalog Code: 190-9527
- Lot Numbers: 010211
- 040411
Distribution
Part of a larger recall action
This product is one of 10 recalled by Instrumed International, Inc. 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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