Stradis Healthcare recalls surgical suture kits with specific part numbers due to uncertainty about sterile barrier integrity. Affected kits may not maintain sterility during use.
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Stradis Healthcare is recalling surgical suture kits with part numbers ZZ-0958 and specific lot numbers because there's uncertainty about whether the sterile barrier stays intact. This could lead to infections or contamination during procedures.
The sterile barrier in the suture kits may not hold up properly, potentially allowing contamination during surgery. This uncertainty could lead to infections or other complications for patients.
Healthcare professionals using the recalled suture kits are most at risk. Patients undergoing surgery with these kits could face infection or contamination.
Check for part number ZZ-0958 and lot numbers 213639474, 212957814, or 212675717 on the packaging or label. The kits were sold with specific identifiers that indicate the affected batches.
Identify the part number (ZZ-0958) and lot numbers (213639474, 212957814, 212675717) on the suture kit packaging.
The recall is due to uncertainty about the sterile barrier integrity, which could lead to contamination during surgery.
Check for part number ZZ-0958 and lot numbers 213639474, 212957814, or 212675717 on the packaging or label.
The recall record does not specify a remedy, so contact Stradis Healthcare directly for guidance.
We’ve drafted a message you can send Strad:is Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1132-2022 — Strad:is Healthcare Strad:is Healthcare Hello, I own a Strad:is Healthcare that is covered by recall Z-1132-2022 from Strad:is Healthcare. 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.
