Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53" LIF (1) DRAPE BOTTOM ASS REINFORCED 71" X 71" WITH TAPE LIF (1) CAUTERY TIP POLISHER LIF (3) SURGICAL BLADE #1 0 CARBON STEEL (15) LAP SPONGE PREWASH XRD LIF (1) BAG GLASSINE (2) DRAPE SIDE WITH ADHESIVE 36" X 77" (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (1) LITES GLOVE LIF (3) SURGICAL BLADE #15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) WRAPPER 24" X 24" (3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IV 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 900-169, 8 lots: 111010061 111040963 111071906 112041402 112051862 113036593 113046891 113088753
- 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:
Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53" LIF (1) DRAPE BOTTOM ASS REINFORCED 71" X 71" WITH TAPE LIF (1) CAUTERY TIP POLISHER LIF (3) SURGICAL BLADE #1 0 CARBON STEEL (15) LAP SPONGE PREWASH XRD LIF (1) BAG GLASSINE (2) DRAPE SIDE WITH ADHESIVE 36" X 77" (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (1) LITES GLOVE LIF (3) SURGICAL BLADE #15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) WRAPPER 24" X 24" (3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Product Codes/Lot Numbers:
Product code 900-169, 8 lots: 111010061 111040963 111071906 112041402 112051862 113036593 113046891 113088753
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2310-2014
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.