SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18" X 18" XRD (2) U-DRAPE 60" X 70" WITH TAPE SPLIT (2) DRAPE SHEET 41" X 58" SMS (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TABLE COVER REINFORCED 50" X 90" (1) COBAN WRAP TAN 4" X 5yds (1) TIME OUT BEACON NON WOVEN (2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK WITH 8 LABEL (1) TUBE CONNECTING SUCTION X" X 12' (1) MAYO TRAY SMALL ( 1) CAMERA COVER W/ELAST. 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: Product code 900-2193, 28 lots 111082204 111092380 111113084 111123219 111123426 112041379 112083164 112093928 113015445 113026056 113036438 113036728 113046937 113057461 113067867 113078470 113078790 113099287 113109790 131110074 131110499 131210647 131210968 140111415 140311935 140312380 140412834 140513127
- 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:
SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18" X 18" XRD (2) U-DRAPE 60" X 70" WITH TAPE SPLIT (2) DRAPE SHEET 41" X 58" SMS (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TABLE COVER REINFORCED 50" X 90" (1) COBAN WRAP TAN 4" X 5yds (1) TIME OUT BEACON NON WOVEN (2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK WITH 8 LABEL (1) TUBE CONNECTING SUCTION X" X 12' (1) MAYO TRAY SMALL ( 1) CAMERA COVER W/ELAST. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-2193, 28 lots 111082204 111092380 111113084 111123219 111123426 112041379 112083164 112093928 113015445 113026056 113036438 113036728 113046937 113057461 113067867 113078470 113078790 113099287 113109790 131110074 131110499 131210647 131210968 140111415 140311935 140312380 140412834 140513127
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2439-2014
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.