3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part Number: 0215-015-200 and lot numbers: 10074012 10280012 11110012 11271012 12066012 12349012 13225012 14022012 10105012 10294012 11138012 11298012 12080012 13016012 13260012 14070012 10118012 10315012 11151012 11346012 12091012 13077012 13268012 14163012 10155012 10319012 11185012 11356012 12181012 13115012 13303012 14169012 10215012 10344012 11189012 12025012 12275012 13120012 13323012 14195012 10242012 11025012 11264012 12053012 12290012 13148012 13346012 14246012 10252012 11033012
  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:
Stryker Instruments Div. of Stryker Corporation
Reason for Recall:
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Product Codes/Lot Numbers:

Part Number: 0215-015-200 and lot numbers: 10074012 10280012 11110012 11271012 12066012 12349012 13225012 14022012 10105012 10294012 11138012 11298012 12080012 13016012 13260012 14070012 10118012 10315012 11151012 11346012 12091012 13077012 13268012 14163012 10155012 10319012 11185012 11356012 12181012 13115012 13303012 14169012 10215012 10344012 11189012 12025012 12275012 13120012 13323012 14195012 10242012 11025012 11264012 12053012 12290012 13148012 13346012 14246012 10252012 11033012

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1563-2015

Related Recalls

When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.

Jun 15, 2022 Surgical Instruments View Details →

Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.

Jan 22, 2020 Other Medical Devices Nationwide View Details →