PlainRecalls
FDA Devices Critical Class I Terminated

LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG G

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2447-2014

Product Description

LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN (1) CAUTERY TIP POLISHER LIF (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM (1) TIME OUT BEACON NON WOVEN LIF (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reason for Recall

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.

Details

Recalling Firm
Customed, Inc
Units Affected
1 lot/60 units
Distribution
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.
Location
Fajardo, PR

Frequently Asked Questions

What product was recalled?
LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN (1) CAUTERY TIP POLISHER LIF (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM (1) TIME OUT BEACON NON WOVEN LIF (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 1 lot/60 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2447-2014.