FDAFDA · Food and drugs·Recall number Z-0655-2020
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Published December 18, 2019 · Recall initiated: October 18, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed to meet USP minimum average value for knot pull (tensile) strength.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- CP Medical Inc
- Distributor
- USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
- Lot
- Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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