Recall Z-1872-2017 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
CP Medical Inc
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
| Date | Feb 2, 2017 |
| Status | Open, Classified |
| Reason | The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life. |
| Root cause | Unknown/Undetermined by firm |
| Action | The affected distributors/customers were contacted directly via telephone or by e-mail on February 6-7, 2017. Those end users not contacted by CP Medical directly will be contacted by their distributor |
| Quantity | 504 boxes/12 sutures - 6,048 individual sutures |
| Distribution | AL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KY, LA, MT, NE, NJ, NM, NY, OK, OR, SC, TX, WA and South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072229 | MONOSWIFT Cp Medical, Oct 5, 2007 |