Recall Z-2220-2019— ROi Consolidated Service Center (CSC)
Class II · Ongoing
Class II FDA medical device recall by ROi Consolidated Service Center (CSC), initiated 2019-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" 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: 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..
- Recalling firm
- ROi Consolidated Service Center (CSC)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-03-21
- Firm location
- Springfield, MO, United States
Product description
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.