MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF (5) LAP SPONGE PREWASH XRD L/F (4) DRAPE UTILITY WITH TAPE LIF (2) LITES GLOVE LIF (1) TUBE SUCTION CONNECT. ~" X 12' LIF (1) COVER MAYO STAND REINFORCED LIF (1) UTILITY BOWL 32oz (2) UTILITY BOWL 16oz (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL #10 CARBON STEEL (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BAG SUTURE FLORAL (1) DRAPE SHEET MEDIUM 41" X 69" LIF (1) DRAPE LAP WITH POUCH SMS STD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product code 900-1735, 50 lots: 110102434 110112619 110112893 111010068 111020366 111030604 111040842 111051280 111061589 111071909 111082065 111082258 111092365 111102646 111102700 111112936 111112963 111123380 112010087 112010246 112020405 112030642 112041200 112051874 112062448 112072785 112083406 112114610 112125032 112125313 113015434 113025948 113026232 113036783 113057399 113057692 113057813 113068157 113078569 113089200 113099567 131110069 131110403 131110580 131210964 140111412 140211885 140312330 140412886 140513347
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:

MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF (5) LAP SPONGE PREWASH XRD L/F (4) DRAPE UTILITY WITH TAPE LIF (2) LITES GLOVE LIF (1) TUBE SUCTION CONNECT. ~" X 12' LIF (1) COVER MAYO STAND REINFORCED LIF (1) UTILITY BOWL 32oz (2) UTILITY BOWL 16oz (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL #10 CARBON STEEL (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BAG SUTURE FLORAL (1) DRAPE SHEET MEDIUM 41" X 69" LIF (1) DRAPE LAP WITH POUCH SMS STD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Product Codes/Lot Numbers:

Product code 900-1735, 50 lots: 110102434 110112619 110112893 111010068 111020366 111030604 111040842 111051280 111061589 111071909 111082065 111082258 111092365 111102646 111102700 111112936 111112963 111123380 112010087 112010246 112020405 112030642 112041200 112051874 112062448 112072785 112083406 112114610 112125032 112125313 113015434 113025948 113026232 113036783 113057399 113057692 113057813 113068157 113078569 113089200 113099567 131110069 131110403 131110580 131210964 140111412 140211885 140312330 140412886 140513347

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2409-2014

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