GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079
This recall has been terminated (originally issued September 25, 2010).
- Company
- Ams Innovative Center San Jose
- Recall Initiated
- January 22, 2010
- Posted
- September 25, 2010
- Terminated
- January 25, 2011
- Recall Number
- Z-2502-2010
- Quantity
- 11668 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Product may be packed with incorrect external or internal labels and/or missing product insert.
Distribution
Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.
Lot / Code Info
Manufactured between August 21 and October 31, 2009-- Lot number/Affected units: 932: D, N, U, Z; 933: A, C, F, H, K, L, M, T; 934: B, D, N, U, V, W, Y, Z; 935: A, C, F, H, K, L, M, T; 936: B, D, N, U, V, W, Y, Z; 937: A, C, F, H, K, L, M, T; 938: B, D, N, U, V, W, Y, Z; 939: A, B,L, M, T, V, W, Y; 940: B, D, N, U, V, W, Y, Z.
Root Cause
Labeling mix-ups
Action Taken
Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.