CP Medical recalls sterile Plain and Chromic Gut Absorbable Surgical Sutures (12 per box) after endotoxin tests showed potential sterility compromise. Affected lots include 822PG-HUF (170927-52, 180611-59), 822PG-DAR (171205-52), 810PG-1 (180924-51), and 822PG-1 (180924-53).
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
CP Medical is recalling sterile surgical sutures that may have lost sterility after routine endotoxin testing. This could lead to infections if used in procedures. Patients and healthcare providers should check their lot numbers and contact CP Medical if affected.
The sutures were found to have an out-of-limit endotoxin test result, which could mean they are not sterile. If used in surgery, this might cause infections. However, the risk is low because the issue was detected during routine testing.
Healthcare providers and patients using the recalled sutures for surgeries. Those with the specific lot numbers listed are most at risk.
Check the product label for lot numbers: 822PG-HUF (170927-52, 180611-59), 822PG-DAR (171205-52), 810PG-1 (180924-51), or 822PG-1 (180924-53). The sutures come in boxes of 12.
Look for the lot number on the sutures packaging to see if it matches the affected lots listed.
The recall indicates a potential sterility issue detected during routine testing, but the sutures are safe if not used in procedures with the affected lots.
Check the lot number on the packaging. If it matches the affected lots, contact CP Medical for instructions.
The affected lots are 822PG-HUF (170927-52, 180611-59), 822PG-DAR (171205-52), 810PG-1 (180924-51), and 822PG-1 (180924-53).
We’ve drafted a message you can send CP Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1027-2019 — CP Medical CP Medical Hello, I own a CP Medical that is covered by recall Z-1027-2019 from CP Medical. 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.
