Medical convenience kit recalled for visualization system discoloration from resterilization
AVID Medical is recalling GENERAL ROBOTIC PACK medical kits due to discoloration of the CLEARIFY VISUALIZATION SYSTEM caused by inadvertent resterilization. A total of 203 units were distributed across seven states.
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: The affected product is an FDA Class II medical device. No injuries or illnesses have been reported. However, the physical defect—discoloration from inadvertent resterilization—in a critical visualization component represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling GENERAL ROBOTIC PACK medical convenience kits. The recall is due to discoloration of the CLEARIFY VISUALIZATION SYSTEM component, which was caused by inadvertent resterilization during kit preparation.
A total of 203 units have been distributed to California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. The affected kits can be identified by model numbers NAFB082-04 and NAMC473-01. Lot numbers are: 1568211, 1576237, 1599515, 1599516, 1605944, 1613558, 1616420, 1613626, 1625831, 1627259, 1628672, 1632042, and 1635911.
Customers who have received affected kits should contact AVID Medical, Inc. for replacement or return instructions.
The recalled product
- Product
- GENERAL ROBOTIC PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
- sterilization-defect
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 (17)
- Model No. NAFB082-04
- NAMC473-01
- UDI: 10809160395691
- 10809160375037
- Kit Lot No. 1568211
- 1576237
- 1599515
- 1599516
- 1605944
- 1613558
- 1616420
- 1613626
- 1625831
- 1627259
- 1628672
- 1632042
- 1635911.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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