DeRoyal recalls sterile surgical kits with Medline Aplicare Povidone Iodine Prep Pads that may expire before the 36-month label date due to a manufacturing issue.
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
DeRoyal is recalling sterile surgical kits that contain Medline Aplicare Povidone Iodine Prep Pads. These pads may expire before the 36-month date listed on the label because Medline determined the product wouldn't support that expiration.
The Medline Aplicare Povidone Iodine Prep Pads in these kits were found by Medline to not meet the 36-month expiration requirement. This means the pads might degrade or become ineffective before the labeled date, potentially affecting surgical procedures.
Surgical teams and hospitals that use DeRoyal Sterile Custom kits with Medline Aplicare Povidone Iodine Prep Pads are likely affected. The risk is low as the issue relates to expiration dates rather than immediate safety hazards.
Check for DeRoyal Sterile Custom kits labeled with specific lot numbers: Shoulder Arthroscopy Packs (89-8686.01 and 89-8686.02) and Knee Arthro Packs (89-8687.01 and 89-8687.02).
Look for lot numbers listed in the product descriptions: Shoulder Arthroscopy Packs (89-8686.01, 89-8686.02) and Knee Arthro Packs (89-8687.01, 89-8687.02).
Medline determined the prep pads would not support the 36-month expiration date listed on the label.
No, the recall is for potential expiration issues, not an immediate safety hazard. Continue using as normal but check expiration dates.
Check the kit labels for the specific lot numbers mentioned. If you have the affected kits, contact DeRoyal for further instructions.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0334-2018 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0334-2018 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.
