NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W' X I 2' LIF (I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF (I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23" X 1 7" LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF (2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77" X 110" HD FULL L/F (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF ( I ) DRAPE T LAPAROTOMY 102" X 78" X 1 21" STD SMS (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE 'l'4 ECONOMY 53" X 77" LIF (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF 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 900-2765, 6 lots 112124939 113036441 113056798 113057644 113078320 113088806
- 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:
NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W' X I 2' LIF (I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF (I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23" X 1 7" LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF (2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77" X 110" HD FULL L/F (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF ( I ) DRAPE T LAPAROTOMY 102" X 78" X 1 21" STD SMS (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE 'l'4 ECONOMY 53" X 77" LIF (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Code 900-2765, 6 lots 112124939 113036441 113056798 113057644 113078320 113088806
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2504-2014
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.