Ellman Minor Surgery Bipolar Cable Recalled for Mismatched Expiration Dates
Ellman International is recalling 370 boxes of Minor Surgery Bipolar Cables because the expiration dates on the outer boxes and individual pouches do not match.
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 and involves a minor labeling error regarding expiration dates, which fits the rubric criteria for moderate severity involving minor labeling errors.
Plain-English summary
Ellman International, Inc. is recalling 370 boxes of the Minor Surgery Bipolar Cable, which contains five disposable bipolar cables. The recall is due to a labeling error where the expiration date printed on the outer box does not match the expiration date on the individual pouches. The source text confirms that the expiration date on the box is correct and is listed as 2018-02.
The affected product is an accessory used to connect bipolar handpieces to an RF generator for electrosurgical procedures. The recall covers 159 boxes distributed in the United States and 211 boxes distributed internationally. The specific lot numbers involved are 45572 for the box and 48543, 50382, 48543, 50704, and 50858 for the individual packages.
Healthcare providers and consumers should stop using the affected cables and contact Ellman International for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar…
- Manufacturer
- Ellman International, Inc.
- Hazard
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 (6)
- Lot Numbers 45572 (Box)
- (Individual packages) 48543
- 50382
- 48543
- 50704
- 50858 Exp Date - 2018-02
Distribution
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