ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets
ROi is recalling 312 custom surgical packs containing Stryker Pneumosure tubesets due to a risk of tube detachment and gas leakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (tube detachment) that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation (ROi) is recalling 312 custom surgical packs labeled as "LAPAROSCOPIC - OSU". These packs contain Stryker Pneumosure tubesets, specifically part numbers 0620 040 660, 0620 040 690, and 0620 040 680. The affected lots are identified by item numbers 880341004 and 880341005, with specific lot numbers and expiration dates listed in the recall notice.
The recall was initiated after ROi received a notice from Stryker regarding a defect where the tube sets may detach from the cassette. This detachment can result in leaking gas or a hissing sound during use. The affected products were distributed to locations in Louisiana (LA) and Missouri (MO).
Healthcare facilities and consumers who possess these specific surgical packs should stop using them immediately. Users should contact ROi Consolidated Service Center (CSC) for instructions on how to return the products or obtain a replacement, as directed by the recall notice.
The recalled product
- Product
- 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.
- Manufacturer
- ROi Consolidated Service Center (CSC)
- Hazard
- Affected units
- 312
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Item Number (Lot Number
- Expiration Date): 880341004 (043444D
- 43566)
- 880341005 (047474E
- 43706)
- 880341005 (049043E
- 43750)
Distribution
Part of a larger recall action
This product is one of 2 recalled by ROi Consolidated Service Center (CSC) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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