PlainRecalls
FDA Devices Critical Class I Terminated

Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100 (3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP (1) WRAPPER 24" X 24" UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF (1) DRAPE LAP ABDO. W/POU

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2517-2014

Product Description

Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100 (3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP (1) WRAPPER 24" X 24" UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF (5) APPLICATOR COTTON 6 WOOD UF (1) ULTRA VERES NEEDLE 120MM LIF (1) APPLIER MUL Tl CLIP W/SHAF GUN (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF (2) DRAPE :Y. ECONOMY 53" X 77" UF (2) UTLITY BOWL 16oz. UF (1) SCALPEL WEIGHTED SAFETY #11 UF (1) RING BASIN (1) TIME OUT BEACON NON WOVEN UF (1) TUBE SUCTION CONNECT (1) MERLING SKIN PREP APPLIC 39ML UF (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF (2) TOWEL CLOTH HUCK (BLUE) UF (1 0) GAUZE SPONGE 4 X 4 16PL Y UF (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF (2) LIGHT SHIELD UF (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 (1) PK. STERI STRIP CLOSURE (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL (1) SYRINGE 30ML SLIP TIP 1 ML UF 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/ 20 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? ▼
Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100 (3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP (1) WRAPPER 24" X 24" UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF (5) APPLICATOR COTTON 6 WOOD UF (1) ULTRA VERES NEEDLE 120MM LIF (1) APPLIER MUL Tl CLIP W/SHAF GUN (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF (2) DRAPE :Y. ECONOMY 53" X 77" UF (2) UTLITY BOWL 16oz. UF (1) SCALPEL WEIGHTED SAFETY #11 UF (1) RING BASIN (1) TIME OUT BEACON NON WOVEN UF (1) TUBE SUCTION CONNECT (1) MERLING SKIN PREP APPLIC 39ML UF (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF (2) TOWEL CLOTH HUCK (BLUE) UF (1 0) GAUZE SPONGE 4 X 4 16PL Y UF (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF (2) LIGHT SHIELD UF (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 (1) PK. STERI STRIP CLOSURE (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL (1) SYRINGE 30ML SLIP TIP 1 ML UF 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/ 20 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-2517-2014.

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