Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15" X 20" L/F (1) NEEDLE HYPODERMIC 27G X 1 %" LIF (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED L/F (1) PVP SCRUB SOLUTION 4oz (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) COVER TABLE REINFORCED 44" X 78" LIF (1) CUP DENTURE 8oz TEAL WITH LID (12) TOWEL CLOTH HUCK C BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) TUBING INFILTRATION PERISTALTIC PUMPS (4) CLAMP TOWEL LIF (3) SHEET DRAPE 70" X 100" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2520-2014
- 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
Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15" X 20" L/F (1) NEEDLE HYPODERMIC 27G X 1 %" LIF (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED L/F (1) PVP SCRUB SOLUTION 4oz (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) COVER TABLE REINFORCED 44" X 78" LIF (1) CUP DENTURE 8oz TEAL WITH LID (12) TOWEL CLOTH HUCK C BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) TUBING INFILTRATION PERISTALTIC PUMPS (4) CLAMP TOWEL LIF (3) SHEET DRAPE 70" X 100" LIF 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.
900-3028, 2 lots: 113099553 140613790
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.
2 lots/30 units, multiple units per lot