Device product
TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2425-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1 lot; 50 units (multiple units per lot)
- Official record key
device-enforcement:Z-2425-2014
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: Product code 900-1983, 1 lots: 131110141
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