Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);
  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:
ROi Consolidated Service Center (CSC)
Reason for Recall:
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Product Codes/Lot Numbers:

Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);

Distribution:

Distributed in: LA, MO

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2221-2019

Related Recalls

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Mar 21, 2019 Surgical Instruments View Details →