Recall Z-0655-2020— CP Medical Inc

Name: FDA recall Z-0655-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-18

Class II · Ongoing

Class II FDA medical device recall by CP Medical Inc, initiated 2019-10-18. It names one FDA 510(k) clearance: K002190. Product: Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970. Reason: Failed to meet USP minimum average value for knot pull (tensile) strength..

Recalling firm: CP Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-10-18
Firm location: Norcross, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K002190 — POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)Cp Medical·cleared 2000-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.