Richard Wolf Recalls S(a)line Resectoscope Vaporization Electrodes Due to Packaging Error
Richard Wolf Medical Instruments Corp. is recalling S(a)line resectoscope vaporization electrodes because a different model was found packaged in the wrong pouch.
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 the source text describes a packaging error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Richard Wolf Medical Instruments Corp. is recalling 78 cartons (234 units) of S(a)line resectoscope vaporization electrodes. The recall was initiated after the company received a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch. The affected units are labeled with REF 4630022 or 46300223, Lot 426111, and an expiration date of 2016/06.
These devices are used for endoscopically controlled removal of tissue using saline as the irrigation medium. The affected products were distributed nationwide, including in California, Georgia, Illinois, Kentucky, Louisiana, Michigan, Maryland, New York, Oregon, Texas, Virginia, and Puerto Rico.
Consumers and healthcare facilities should stop using the affected units and contact Richard Wolf Medical Instruments Corp. for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF…
- Manufacturer
- Richard Wolf Medical Instruments Corp.
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 (4)
- *** Individual Units *** Product Code: 4630022 (single)
- Lot: 426111
- Expiration Date: 2016/06
- *** Cartons *** Product Code: 46300223 (box of 3)
Distribution
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