Stryker recalls QUIKFLAP surgical covers (part 12-01536S) due to potential packaging compromise after 3 years. Affected units sold with serial numbers 1000232402 and 1000237513.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Stryker is recalling QUIKFLAP surgical covers that may have compromised sterile packaging after three years. This could lead to infection risks if the packaging is no longer intact.
The sterile packaging may become compromised after three years of storage, potentially allowing contamination. This could increase infection risk during surgical procedures if the packaging is no longer intact.
Surgical teams and hospitals using the QUIKFLAP covers with serial numbers 1000232402 or 1000237513. Patients undergoing surgery are at risk if the packaging becomes compromised.
Check for the part number 12-01536S and serial numbers 1000232402 or 1000237513 on the packaging. These covers are used for cranium procedures.
Inspect the sterile barrier packaging for signs of damage or compromise.
The recall is due to potential packaging compromise after three years of storage, which could increase infection risk during surgery.
Look for part number 12-01536S and serial numbers 1000232402 or 1000237513 on the packaging.
Inspect the packaging for damage or compromise. If compromised, contact Stryker for guidance.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2908-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2908-2018 from Stryker. 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.
