PlainRecalls
FDA Devices Critical Class I Terminated

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) SYRI

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2520-2014

Product 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.

Reason for Recall

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.

Details

Recalling Firm
Customed, Inc
Units Affected
2 lots/30 units, multiple units per lot
Distribution
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.
Location
Fajardo, PR

Frequently Asked Questions

What product was recalled?
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.. Recalled by Customed, Inc. Units affected: 2 lots/30 units, multiple units per lot.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2520-2014.