DeRoyal recalls custom sterile surgical packs with Terumo Over Pressure Safety Valve due to reported 'No Flow' issues. Affected packs have specific lot numbers and labels.
DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
DeRoyal is recalling custom sterile surgical packs that contain a Terumo Over Pressure Safety Valve. The recall is due to reports of 'No Flow' through this valve, which could lead to improper surgical procedures.
The Terumo Over Pressure Safety Valve in these packs may not allow proper fluid flow during surgery. This could lead to improper surgical procedures if the valve fails to function correctly.
Surgical teams using these custom sterile packs for procedures like shoulder arthroscopy are most at risk. The affected packs have specific lot numbers and labels.
Look for packs labeled 'GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO' with lot numbers 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, or 46203903.
Look for the specific label and lot numbers listed in the recall notice to confirm if your pack is affected.
The recall is due to reports of 'No Flow' through the Terumo Over Pressure Safety Valve, which could lead to improper surgical procedures.
The official recall notice does not specify a remedy or action steps beyond checking the label for affected lot numbers.
These packs are labeled for use in shoulder arthroscopy procedures.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0637-2018 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0637-2018 from DeRoyal. 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.
