EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60"X 70" WITH TAPE SPLIT 6" X 21" (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15" X 20" (3) DRAPE % ECONOMY 53" X 77" (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146" X 104" X 91" (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2456-2014
- 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
EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60"X 70" WITH TAPE SPLIT 6" X 21" (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15" X 20" (3) DRAPE % ECONOMY 53" X 77" (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146" X 104" X 91" (1) TABLE COVER REINFORCED 50" X 90" 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 900-2438 ,4 lots 140211465 140211702 140412558 140512912
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.
4 lots/112 units (multiple units per lot)