Device product
CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK TOWEL BLUE (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) GOWN SURGICAL REINF XL TOWEL/WRAP (1) NEEDLE HYPODERMIC 18G X 1 %" (10) GAUZE SPONGE 4" X 4" 16PLY XRD L.F (1) UTILITY BOWL 16oz LIF (1) ABSORBENT TOWELS 15" X 20" LIF (1) CAST PADDING (2) SURGICAL BLADE #15 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET EXTREMITY ABS. 125" x 85" SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2348-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 38 lots; 3066 units (multiple units per lot)
- Official record key
device-enforcement:Z-2348-2014
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 900-742, 38 lots: 110092282 110112680 110122944 111010190 111020296 111041070 111061687 111071387 111071969 111082110 111092402 111102779 111113140 111123292 112010203 112020493 112030743 112041353 112052012 112062507 112093642 112104103 112114589 112125112 113015460 113025776 113025985 113036767 113067963 113068180 113088888 113099453 113109871 131110275 131210841 140111250 140211737 140311948
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