Recall Z-1872-2017— CP Medical Inc

Name: FDA recall Z-1872-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-02

Class II · Ongoing

Class II FDA medical device recall by CP Medical Inc, initiated 2017-02-02. It names one FDA 510(k) clearance: K072229. Product: PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493. Reason: The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life..

Recalling firm: CP Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2017-02-02
Firm location: Norcross, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K072229 — MONOSWIFTCp Medical·cleared 2007-10-05

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

PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

Reason for recall

The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.

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