Device product
Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) YANKAUER SUCTION TUBE W/O VENT ( 1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2495-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1 lot/ 120 units
- Official record key
device-enforcement:Z-2495-2014
Official wording
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Code information: Code 900-2682, 1 lot: 112093710
Distribution pattern: Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Derived failure modes
-
Labeling or packaging
packaging integrity may be compromised
-
Sterility assurance
loss of sterility