Device product
Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10
Z-1945-2018
Product summary
- Firm
- Olsen Medical
- Event
- Event 80080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,110 devices
- Official record key
device-enforcement:Z-1945-2018
Official wording
Reason: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Code information: all codes
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Labeling or packaging
pouch seal thereby increasing the risk of the seal being compromised
-
Sterility assurance
sterile pouch seal thereby increasing the risk of the seal being compromised