Reported Dec 18, 2019 · Ongoing

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430…

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?

  • Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm)
  • UDI(01)10790986000657 (17)220430 (10)17050970
Lot codes and dates
  • Product Code494A/494A-IMC
  • Lot Number190123-59
  • date of manufacture03/04/2019
Amount recalled
174 boxes 12 per box (plus 36 samples) - total of 2124 sutures

Where it was sold

Why it was recalled

Failed to meet USP minimum average value for knot pull (tensile) strength.

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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