Device product
Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-LF
Z-1095-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1095-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Product/Lot Number: P151659 BIOPSY TRAY 2019031490 P243133 LATEX TUBING PACK 2019042590 P243133 LATEX TUBING PACK 2019031990 P243133 LATEX TUBING PACK 2019022190 P261569 PACK BIOPSY 2019021490 P392929 BMT-LACERATION PACK 2018121790 P429589A TRAY BONE MARRO ASC LTX SAFE 2019012590 P734457 SUTURE REMOVAL PACK LATEX SAFE 2019031990 P751651A BIOPSY PROCEDURE PACK 2019020890 P758486 PVP PREP PACK 2019041590 P758486 PVP PREP PACK 2019031990 P922260 ALCOHOL PREP PACK 2019041580 P928310 WET PREP TRAY 2019050690 P928310 WET PREP TRAY 2019031590 P948416 LACERATION PACK 2018110990 P966455A BREAST BIOPSY PACK-LF 2018122790
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility