Medical Vision Ab Recalls Double Pump RF Patient Cassettes
Medical Vision Ab is recalling 3,295 Double Pump RF Patient Cassettes because sterile package breakage may compromise device sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, posing a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medical Vision Ab is recalling 3,295 Double Pump RF Patient Cassettes (Product Number: 72204055). These devices are intended to provide fluid distension, irrigation, and fluid suction during diagnostic and operative arthroscopic procedures.
The recall is being conducted because the sterility of the device may be compromised due to sterile package breakage. The affected units were distributed to the United States, specifically to the states of NH, OK, AL, PA, IL, MA, TX, MI, NC, CA, MN, CT, GA, NY, WI, KY, OH, VA, NJ, TN, SD, and IN. The recall includes all lot numbers of Double Pump RF Patient Cassettes delivered to the US, with specific batch numbers ranging from 13I03 to 14J03.
Healthcare facilities and consumers should stop using these devices and contact Medical Vision Ab for further instructions on how to return or dispose of the affected cassettes.
The recalled product
- Product
- Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
- Manufacturer
- Medical Vision Ab
- Affected units
- 3,295
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)
- All lot numbers of Double Pump RF Patient Cassettes delivered to the US
- Batch numbers: 13I03
- 14A01
- 14A06
- 14A09
- 14A10
- 14B03
- 14B09
- 14C06
- 14C10
- 14D07
- 14D11
- 14E06
- 14E10
- 14F01
- 14F02
- 14F03
- 14F04
- 14F10
- 14F11
Distribution
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