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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Code 900-3025, 1 lot: 131110114
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Customed, Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Code 900-3025, 1 lot: 131110114
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2517-2014
Related Recalls
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.