Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN STAPLE 35 WIDE LIF (1) MAYO TRAY LARGE (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F (1) BULB SYRINGE 60cc (1) UTILITY BOWL 16oz (1) UTILITY BOWL QUART 32oz (1) INCISION DRAPE 23" X 17" (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) MERLING SKIN PREP APPLIC. 39ML UF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX (1) * GLOVE # 8 SURGEON NEUTRALON LATEX (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP (4) UTILITY DRAPE WITH TAPE UF (1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF (2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds (1) BLADE SURGICAL# 20 STAINLESS STEEL (2) LITE GLOVE UF (1) STOCKINETIE IMPERVIOUS 12" X 48" (1) CAUTERY PENCIL ROCKER SWITCH UF (1) BANDAGE ESMARK 6" X 9yds UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2479-2014
- 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
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN STAPLE 35 WIDE LIF (1) MAYO TRAY LARGE (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F (1) BULB SYRINGE 60cc (1) UTILITY BOWL 16oz (1) UTILITY BOWL QUART 32oz (1) INCISION DRAPE 23" X 17" (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) MERLING SKIN PREP APPLIC. 39ML UF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX (1) * GLOVE # 8 SURGEON NEUTRALON LATEX (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP (4) UTILITY DRAPE WITH TAPE UF (1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF (2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds (1) BLADE SURGICAL# 20 STAINLESS STEEL (2) LITE GLOVE UF (1) STOCKINETIE IMPERVIOUS 12" X 48" (1) CAUTERY PENCIL ROCKER SWITCH UF (1) BANDAGE ESMARK 6" X 9yds UF 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 900-2614, 1 lot: 140312137
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.
1 lot (30 packed units)