Device product
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.
Z-2520-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 lots/30 units, multiple units per lot
- Official record key
device-enforcement:Z-2520-2014
Official wording
Reason: 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.
Code information: 900-3028, 2 lots: 113099553 140613790
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
packaging integrity may be compromised
-
Sterility assurance
loss of sterility