DeRoyal's CRANI PACK surgical packs (REF 89-9211.07) are recalled due to potential sterility compromise from defective blunt cannulas. Affected units include Lot 49888830.
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
DeRoyal's CRANI PACK custom surgical packs (REF 89-9211.07) are being recalled because the blunt cannulas inside may have a manufacturing defect that could compromise the sterility barrier. This could lead to infections if the packs are used without proper sterility.
The surgical packs contain Cardinal Health blunt cannulas that have a manufacturing defect in the cartridge component. This defect could compromise the sterility barrier of the product, potentially leading to infections if the packs are used without proper sterility.
Surgical teams and hospitals that use DeRoyal CRANI PACK surgical packs with the specific reference number REF 89-9211.07 are most at risk. Patients receiving procedures using these packs could face infection risks if sterility is compromised.
Check for the product name 'CRANI PACK', reference number REF 89-9211.07, and lot number 49888830 on the packaging or label. These packs are sold by DeRoyal Industries Inc.
Identify the reference number REF 89-9211.07 and lot number 49888830 on the packaging to confirm if your pack is affected.
The packs contain Cardinal Health blunt cannulas with a manufacturing defect that could compromise the sterility barrier of the product.
The official recall notice does not specify a remedy or action for affected units.
The recall is due to potential sterility compromise, not direct injury risks. The official notice does not mention injury or death.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1981-2019 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1981-2019 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.
