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Open, Classified

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.

FDA Recall Z-2221-2019 · Posted None

Recall StatusOpen, Classified
Product CodeKDD
Date Initiated2019-03-21
Product Quantity312 packs

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.

Firm 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 [email protected]. Supplemental labels for affected packs will be issued, which will instruct the end user to remove the affected Stryker component(s) and to use single sterile replacement product form inventory. If there is not any affected inventory on hand, customers are requested to still return Attachment A indicating "0" affected inventory at their facility.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to LA and MO

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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