Medical Lubricating Jelly Recalled Due to Temperature Excursions During Storage
Mckesson Medical-Surgical is recalling Fisher Scientific Aseptic Control Lubricating Jelly due to temperature excursions from June–August 2021 that may have reduced product effectiveness.
What this means for you
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: FDA Class II medical device with no reported illnesses or injuries. The hazard is theoretical—temperature exposure may have compromised product effectiveness for its intended use. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Fisher Scientific Aseptic Control Lubricating Jelly for medical use is being recalled by Mckesson Medical-Surgical Inc. The affected product is the 4-ounce lubricating jelly supplied in 12-pack units with Catalog #22998006.
The recall was initiated because the product experienced temperature excursions between June and August 2021 prior to delivery. Exposure to higher temperatures during this period may have reduced the product's intended effectiveness.
The recall affects all lots received between June 1, 2021 and September 30, 2021. The product was distributed nationwide in the United States.
The recalled product
- Product
- FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-degradation
- device-effectiveness
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 (1)
- Not available
Distribution
Distributed nationwide across the United States.
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