FDA-Device2014-09-10Class I
LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY BOWL 32oz (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) EMESIS BASIN 10in 700cc (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (2) TUBE SUCTION CONNEC
Customed, Inc
Hazard
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.
Sold states
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.
Affected count
34 lots; 1136 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY BOWL 32oz (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) EMESIS BASIN 10in 700cc (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (2) TUBE SUCTION CONNECT 114" X 12' LIF (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE LAP. PERINEAL 102" X 97" WITH POUCH (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief