CP Medical Inc: Medical Device Recall in 2019 - (Recall #: Z-0655-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

Product Classification:

Class II

Date Initiated: October 18, 2019

Date Posted: December 18, 2019

Recall Number: Z-0655-2020

Event ID: 84178

Reason for Recall:

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

Status: Ongoing

Product Quantity: 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures

Code Information:

Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019

Distribution Pattern:

USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE

Voluntary or Mandated:

Voluntary: Firm initiated