Device product
Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT 15" X 20" L/F ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF ( 1) MAYO TRAY LARGE (8) DRAPE UTILITY WfTAPE LIF (1 ) TABLE COVER REINFORCED 44" X 78" LIF (2) GOWN SURG. SMS POLY-REINF BREATHABLE AAMI IV X-LARGE T/WRAP ( 1) DRAPE SPLIT CARDIO W/CLEAR ANEST. SC STD SMS ( 1) SHEET SPLIT BILATERAL 84" X 80" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2482-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7 lots, 259 packed units, multiple units for lot.
- Official record key
device-enforcement:Z-2482-2014
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: 900-2618, 7 lots: 113078598 113099489 113109819 131110407 140211729 140412561 140513137
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