Laparoscopic Trays Recalled Due to Visualization System Discoloration
AVID Medical is recalling laparoscopic trays because the visualization system became discolored from inadvertent resterilization. Forty units were distributed to healthcare facilities in CA, IL, MD, OH, PA, TX, and WA.
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: This is an FDA Class II medical device intended for surgical use. The visualization system component was damaged by inadvertent resterilization, causing discoloration. While no illnesses or injuries have been reported, this defect in a critical surgical component represents a risk-of-harm situation and merits a High severity classification.
Plain-English summary
AVID Medical, Inc. is recalling laparoscopic trays because the visualization system became discolored due to inadvertent resterilization. The affected product is model number BJAC006-27 with UDI 10809160394540. The recall includes units from lot numbers 1599252, 1609971, 1612404, and 1640192.
Approximately 40 units were distributed to healthcare facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. The discoloration resulted from an unintended resterilization cycle during kit preparation.
Healthcare facilities that have received these laparoscopic trays should contact AVID Medical immediately for further guidance on replacement or return of the affected units.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- LAPAROSCOPIC TRAY. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- optics-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 (6)
- Model No. BJAC006-27
- UDI: 10809160394540
- Kit Lot No. 1599252
- 1609971
- 1612404
- 1640192.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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