Recall Z-2220-2019 ยท KDD Kit, Surgical Instrument, Disposable
ROi Consolidated Service Center (CSC)
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.
| Date | Mar 21, 2019 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | ROi, Consolidated Service Center ROi, notified customers on about 03/21/2019. Each email included a copy of the ROi "MEDICAL DEVCIE RECALL NOTIFICATION" dated March 21, 2019 as well as the Stryker recall notification dated March 7, 2019. ROi notification letter instructed customers to review inventory to determine if the affected ROi Custom Pack item and lot numbers are in inventory, quarantine all affected packs on hand, and notify ROi of the number of each affected lot on hand by completing and returning "Attachment A" via email to lacy.stewart@roiscs.com. Supplemental labels for affected |
| Quantity | 261 packs |
| Distribution | Distributed to LA and MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.