CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED 3" ADHESIVE CIRCULAR FENESTRATION Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2446-2014
- 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
CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED 3" ADHESIVE CIRCULAR FENESTRATION Product Usage: 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 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128
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.
8 lots/1232 units, (multiple units per lot)