Z-2221-2019 Class II Ongoing
FDA device recall Z-2221-2019 was initiated by ROi Consolidated Service Center (CSC) on March 21, 2019 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 312 packs.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- March 21, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 312 packs
Product 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.
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.
Distribution Pattern
Distributed to LA and MO
Code Information
Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);