DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM HG L/F (4) GAUZE 4" X 4" 4PLY ( I) ALCOHOL PREP PAD MED ( I) CI-ILORASCRUB SWABSTICK 1.6 ( I) LABELCAUTION ( I) DRAPE NON FENESTR. 18" X 26" UF ( I) TAPE TRANSPORE :Y. X 18 LIF ( I) WRAPPER 20" X 20'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2401-2014
- Event ID
- 68536
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2014
- Initiation Date
- May 20, 2014
- Classification Date
- August 29, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, Fajardo, PR, 00738, United States
Description
DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM HG L/F (4) GAUZE 4" X 4" 4PLY ( I) ALCOHOL PREP PAD MED ( I) CI-ILORASCRUB SWABSTICK 1.6 ( I) LABELCAUTION ( I) DRAPE NON FENESTR. 18" X 26" UF ( I) TAPE TRANSPORE :Y. X 18 LIF ( I) WRAPPER 20" X 20'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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.
Product code 900-1538, 12 lots: 113078261 113088739 113089084 113109657 131110181 131210634 140111156 140211646 140312073 140412553 140412914 140613614
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.
12 lots; 2950 units (multiple units per lot)