FDAFDA · Food and drugs·Recall number Z-2221-2019
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.
Published August 14, 2019 · Recall initiated: March 21, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- ROi Consolidated Service Center (CSC)
- Distributor
- Distributed to LA and MO
- Lot
- Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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