Reported Mar 27, 2019 · Ongoing

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are…

CP Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CP Medical Inc · 1775 Corporate Dr Ste 150 · Norcross, GA · 30093-2960

Is this the product you have?

  • Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box
  • Product UsagePlain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues
Lot codes and dates
  • Product Code (lot code)
    • 822PG-HUF (170927-52
    • 180611-59)
    • 822PG-DAR (171205-52)
    • 810PG-1 (180924-51)
    • 822PG-1 (180924-53)
Amount recalled
1,905 boxes (22,860 sutures total)

Where it was sold

Why it was recalled

Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:48 PM UTC

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