Device product
ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET 81" 2.1M REGULAR CLAM (1) NEEDLE HYPODERMIC 18G X 1 ~ (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SHEET DRAPE 70" X 100" LIF (1) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1 ) TUBE SUCTION CONNECT. X" X 12' LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1 ) DURAPREP SURGICAL SOLUTION 26ML LIF (1 ) NEEDLE SPINAL ANEST. 18G X 3 %" LIF (2) ELASTIC BANDAGE 6" X 5YRD. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) PAD ABDOMINAL 8" X 7.5" (1) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2344-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 20 lots; 1356 units (multiple units per lot)
- Official record key
device-enforcement:Z-2344-2014
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 900-740, 20 lots: 112030744 112041351 112052010 112062505 112072876 112093641 112104101 112114588 112125111 113015457 113025967 113036380 113057877 113088887 113099452 113099576 131110272 131210839 140111248 140211735
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