ROi recalls laparoscopic surgical packs with Stryker tube sets that may detach, causing gas leaks or hissing sounds. Affected units include specific part numbers and lot codes.
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.
ROi has recalled laparoscopic surgical packs that include Stryker tube sets which may detach from the cassette, potentially causing gas leaks or a hissing sound. This could lead to complications during surgery if the tubes detach while in use.
The tube sets in the surgical packs can detach from the cassette during use, which may cause gas leaks or a hissing sound. This could lead to complications if the tubes detach while the procedure is ongoing.
Surgical teams using laparoscopic procedures with the recalled packs are most at risk. The affected units are specific to the Stryker part numbers and lot codes listed in the recall.
Check for surgical packs labeled 'LAPAROSCOPIC - OSU' with Stryker part numbers 0620 040 660, 0620 040 690, or 0620 040 680. The lot numbers 880341004, 880341005 (with specific expiration codes) are also affected.
Inspect the tube sets for signs of detachment, such as gas leaks or a hissing sound during use.
Stryker part numbers 0620 040 660, 0620 040 690, and 0620 040 680 are affected.
Look for surgical packs labeled 'LAPAROSCOPIC - OSU' with the specific Stryker part numbers and lot codes listed in the recall notice.
The recall notice does not specify a remedy, so no action is required beyond checking for detachment.
We’ve drafted a message you can send ROi to request your refund or repair — edit it as you like.
Subject: Recall Z-2221-2019 — ROi ROi Hello, I own a ROi that is covered by recall Z-2221-2019 from ROi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
