Device product
Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1) SKIN MARKER WITH RULER (1) TUBE SUCTION CONNECT Y4" X 12' ( 1) CAST PADDING SOFT ROLL 4" X 4yds (10) GAUZE SPONGE 4" X 4" 16PLY ( 1) MERLING SKIN PREP APPLIC 39ML (1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50" X 90" (2) DRAPE SHEET 42" X 55" ( 1) STOCKINETTE 9" x 48" (1) CAUTERY PENCIL ROCKER SWITCH (2) LITE GLOVE ( 1) BANDAGE ESMARK 6" X 9yds ( 1) SHEET EXTREMITY ABS SMS 125" X 85" ( 1) UTILITY BOWL QUART 32oz Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2480-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6 lots (272 packed units, multiple units per lot)
- Official record key
device-enforcement:Z-2480-2014
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: 900-2615, 6 lots: 113099520 131110253 131210797 140211867 140312138 140412662
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